(132 days)
K190959, K192018, K112444, K122037, K130177, K133653, K160528, K073291, K103731, K121760, K123978, K133650, K151128, K120368, K171107, K190165, K133205, K172199, K083026, K100175, K112405, K113528, K132897, K133205, K100214, K111264, K122037, K153373, K172199, K171031, K133216, K094025, K110543, K162212, K150135, K142450, K141599, K182885, K142559, K172199, K090353, K113642, K131669, K132700, K133645, K160418, K152277, K091813, K121982, K162680, K172328, K173125, K181328, K183510
ARTIC-L™ 3D and ARTIC-XL™ 3D Ti Spinal System with TiONIC™ Technology K190959, Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device K192018, K112444, K122037, K130177, K133653, K160528, K073291, K103731, K121760, K123978, K133650, K151128, K120368, K171107, K190165, K133205, K172199, K083026, K100175, K112405, K113528, K132897, K133205, K100214, K111264, K122037, K153373, K172199, K171031, K133216, K094025, K110543, K162212, K150135, K142450, K141599, K182885, K142559, K172199, K090353, K113642, K131669, K132700, K133645, K160418, K152277, K091813, K121982, K162680, K172328, K173125, K181328, K183510
No
The summary describes various spinal fusion devices (cages, plates, screws) and their intended use, materials, and implantation approaches. There is no mention of any software, algorithms, or capabilities that would suggest the use of AI or ML for image processing, diagnosis, treatment planning, or any other function. The focus is entirely on the physical implants and their surgical application.
Yes
The device descriptions and intended uses clearly state that these devices are surgical implants designed to provide support, correction, and facilitate fusion in the spine for various medical conditions like degenerative disc disease, trauma, tumors, and deformities. These are direct medical interventions aimed at treating underlying health issues.
No
The provided text describes various spinal fusion systems and components (cages, plates, bone screws). These devices are used for surgical procedures such as interbody fusion and vertebral body replacement, and their intended use is to provide support and correction during these surgeries. They are therapeutic implants, not diagnostic tools.
No
The device description explicitly states that the devices consist of physical implants such as cages, plates, and bone screws made from materials like PEEK and titanium alloy. These are hardware components, not software.
Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The descriptions clearly state that these devices are implants designed to be inserted into the spine for fusion procedures. They are not used to test blood, tissue, or other bodily fluids in vitro (outside the body).
- The intended use is surgical implantation. The text consistently describes the devices as being used in surgical procedures to provide support, correction, and facilitate fusion of vertebral bodies.
- The device descriptions detail physical implants. The descriptions talk about cages, plates, and screws made of materials like PEEK and titanium, with specific shapes and features for surgical implantation.
Therefore, these devices fall under the category of implantable medical devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ANATOMIC PEEK Cervical Fusion System is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK Cervical Fusion System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open anterior approach.
The ANATOMIC PEEK PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at atone disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patent history and radiographic studies. The ANATOMIC PEEK PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
The CAPSTONE Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.
The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Capstone Control™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had 6 months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.
The CAPSTONE CONTROL PTC™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL PTC™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE CONTROL PTC™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL PTC™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Certain sizes of the CLYDESDALE® Spinal System may be used with INFUSE® Bone Graft in single-level Oblique Lateral Interbody Fusion (OLIF) procedures from L2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the CLYDESDALE® Spinal System approved for use with INFUSE® Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE® Bone Graft. INFUSE® Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. INFUSE® Bone Graft is not indicated for use in patients with this condition. These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.
The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach.
The CRESCENT™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The CRESCENT™ Spinal System Titanium is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 (except as defined for use with INFUSE™ Bone Graft above). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. Certain sizes of the Certain sizes of the DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSE™ Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System interbody device is intended for use with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine when used to treat DDD. Consult the labeling for the INFUSE™ Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System Interbody device approved for use with INFUSE™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE™ Bone Graft. DIVERGENCE-L Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSE™ Bone Graft.
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non- fusion spinal surgery at involved level may be treated with the device.
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Certain sizes of the PEEK PERIMETER® Interbody Fusion Device may also be used with INFUSE® Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The PEEK PERIMETER® Interbody Fusion Device should be used with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the INFUSE™ Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the PEEK PERIMETER Interbody Fusion Device approved for use with INFUSE™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE™ Bone Graft.
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. Certain sizes of the PIVOX™ Oblique Lateral Spinal System Interbody Cage may also be used with INFUSE™ Bone Graft for patients diagnosed with DDD, as defined above, who are skeletally mature and have had six months of non- operative treatment. The device may be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L2- L5 and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the INFUSE™ Bone Graft/ Medtronic Interbody Fusion Device for information on the specific sizes of the PIVOX™ Oblique Lateral Spinal System Interbody Cage approved for use with INFUSE™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE™ Bone Graft. INFUSE™ Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach. Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. INFUSE™ Bone Graft is not indicated for use in patients with this condition. The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1 (except as defined for use with INFUSE™ Bone Graft above). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft and/or allograft bone graft comprised on cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the SOVEREIGN™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non- operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The SOVEREIGN™ interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Corpectomy centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate used at the surgeon's discretion.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, MQP, PLR, ODP, OVE
Device Description
The ANATOMIC PEEK Cervical Fusion System consists of cages of various widths and heights which can be inserted betweentwo cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK devices must be used with supplemental fixation.
The ANATOMIC PEEK™ PTC Cervical Fusion System consists of cages of various widths and heights which can be inserted betweentwo cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK™ PTC devices must be used with supplemental fixation.
The CAPSTONE™ Spinal System consists of PEEK cages, titanium alloy cages, and titanium cages of various widths and heights, which canbe inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The CAPSTONE CONTROL™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. See the MDT Catalog or price list for further information about warranties and limitations of liability.
The CAPSTONE CONTROL PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages ofvarious widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The CAPSTONE PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, or INFUSE® Bone Graft as designated below.
The CLYDESDALE PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The CORNERSTONE® PSR Cervical Fusion System consists of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation and is to be implanted via an open, anterior approach. See the MDT Catalog or price list for further information about warranties and limitations of liability.
The CRESCENT® Spinal System consists of PEEK cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. See the MDT Catalog or price list for further information about warranties and limitations of liability.
The CRESCENT® Spinal System Titanium consists of implant grade titanium alloy (Ti-6Al-4V) cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The implants may be implanted via a transforaminal or lateral approach and the procedure may be open or minimally invasive.
The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages. The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System plate and bone screws are made from titanium alloy and are provided sterile. Additionally, the DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System interbody cages may be used as supplemental fixation when used in conjunction with posterior fixation devices to treat deformity conditions in the thoracic and lumbar spine. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or INFUSE™ Bone Graft (as designated below). The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The DIVERGENCE™ Anterior Cervical Fusion System is an intervertebral body fusion device with internal screw fixation. The system is comprised of an interbody cage and bone screws. These implants are for single use only. The DIVERGENCE™ anterior cervical cages are provided in 0 and 6 degrees of lordosis, 5-12mm heights, 15-20mm widths and 12- 16mm depths. This device is intended to be radiolucent, and the interior space of the product is to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The DIVERGENCE™ stand-alone cervical interbody device is manufactured from medical grade polyetheretherketone (PEEK) and contains radiopaque markers made from medical grade titanium alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, built- in rotary locking mechanism. The bone screws used with this device are provided in self-drilling and self-tapping options and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 9-17mm lengths. The PEEK material used conforms to ASTM F2026 and the titanium alloy material used conformsto ASTM F136. To achieve best results, do not use any of the DIVERGENCE™ Anterior Cervical Fusion System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the DIVERGENCE™ Anterior Cervical Fusion System components should ever be reused under any circumstances.
The ELEVATE™ Spinal System is an expandable PEEK, Tantalum, and Titanium alloy interbody device consisting of various lengths and starting heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The ELEVATE™ Spinal System expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The implants may be implanted via a posterior or transforaminal approach and the procedure may be open or minimally invasive. The ELEVATE™ Spinal System can be implanted unilaterally and bilaterally. The ELEVATE™ Spinal System is intended to be inserted with ELEVATE™ Spinal System reusable instruments. ELEVATE™ Spinal System implants are for single use only.
The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation. The device is offered in Titanium Alloy (Titanium- 6Aluminum-4Vanadium ELI) or PEEK (Polyetheretherketone). This interbody device is offered in sterile or non-sterile forms. Refer to the package label for specific implant sterility information. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in length, and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Allov (Titanium-6Aluminum- 4Vanadium ELI) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. Medical grade titanium, titanium alloy, and/or medical grade cobalt- chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy with stainless steel in the same construct. PEEK implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants. See the MDT Catalog or price list for further information about warranties and limitations of liability.
The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with either autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or INFUSE® Bone Graft as designated below. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum- 4Vanadium ELI) or PEEK (Polyetheretherketone). However, only the PEEK device is approved for use with INFUSE® Bone Graft. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for approved PEEK PERIMETER® implant sizes. This interbody device is offered in sterile or non- sterile forms. Refer to the package label for specific implant sterility information. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum- 4Vanadium ELI) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws. The PIVOX™ Oblique Lateral Spinal System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, or INFUSE™ Bone Graft (as designated below) and must be used with supplemental fixation. The cages are manufactured frommedical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile. The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral Spinal System plate and bone screws are made from titanium alloy and are provided sterile.
The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with 3 holes for placement of titanium screws using an anterior or oblique approach. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the polyetheretherketone (PEEK) interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN™ Spinal System interbody device is manufactured from PEEK (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.
The T2 Stratosphere™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self- adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements. T2 Stratosphere™ Expandable Corpectomy System devices for use in the thoracolumbar and cervical spine are restricted to the 13mm diameter centerpieces. The T2 Stratosphere™ Expandable Corpectomy System is made of titanium alloy and is provided sterile and non-sterile. This device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available in multiple heights. The system also features modular end caps which are available in various angles and diameters and are only for use in the thoracolumbar spine. The device is not intended to be used as a stand-alone implant.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Cervical spine (C2-C3 disc to the C7-T1 disc), Lumbar or Lumbosacral vertebral bodies (L2 to S1, L1-L5, L5-S1), Thoracic and Lumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ARTIC-L™ 3D and ARTIC-XL™ 3D Ti Spinal System with TiONIC™ Technology K190959, Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device K192018, K112444, K122037, K130177, K133653, K160528, K073291, K103731, K121760, K123978, K133650, K151128, K120368, K171107, K190165, K133205, K172199, K083026, K100175, K112405, K113528, K132897, K133205, K100214, K111264, K122037, K153373, K172199, K171031, K133216, K094025, K110543, K162212, K150135, K142450, K141599, K182885, K142559, K172199, K090353, K113642, K131669, K132700, K133645, K160418, K152277, K091813, K121982, K162680, K172328, K173125, K181328, K183510
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2021
Medtronic Sofamor Danek USA, Inc Emmarie Halteman Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K192502
Trade/Device Name: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTCTM Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-LTM Anterior/Oblique Lumbar Fusion System, Elevate™ Spinal System, Perimeter™ Interbody Fusion Device, Pivox™ Oblique Lateral Spinal System, Sovereign™ Spinal System, T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, ODP, OVE, MOP, PLR
Dear Ms. Halteman:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 22, 2020. Specifically, FDA is updating this SE Letter as an administrative correction, to update the Indications for Use and labeling.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840. Brent.Showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 22, 2020
Medtronic Sofamor Danek USA, Inc Ms. Emmarie Halteman Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K192502
Trade/Device Name: Anatomic PEEK™ Cervical Fusion System. Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTCTM Spinal System, Capstone ControlTM Spinal System, Capstone Control PTCTM Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-LTM Anterior/Oblique Lumbar Fusion System, Elevate™ Spinal System, Perimeter™ Interbody Fusion Device, Pivox™ Oblique Lateral Spinal System, Sovereign™ Spinal System, T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, ODP, OVE, MQP, PLR Dated: November 20, 2019 Received: November 22, 2019
Dear Ms. Halteman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Summary Medtronic Sofamor Danek
Medtronic Intervertebral Body Fusion Spinal Systems August 2021
| August 2021 | ||
|---|---|---|
| Submitter | Medtronic Sofamor Danek USA | |
| 1800 Pyramid Place | ||
| Memphis, Tennessee 38132 | ||
| Telephone: (901) 396-3133 | ||
| Fax: (901) 346-9738 | ||
| Contact(s) | Emmarie Halteman | |
| Regulatory Affairs Specialist | ||
| Direct Telephone – 901-399-2216 | ||
| Date | ||
| Prepared | August 6, 2021 | |
| Trade | ||
| Names | ANATOMIC PEEK™ Cervical Fusion System | |
| ANATOMIC PEEK™ PTC Cervical Fusion Spinal System | ||
| Capstone™ Spinal System | ||
| Capstone Control™ Spinal System | ||
| Capstone Control PTC™ Spinal System | ||
| Capstone PTC™ Spinal System | ||
| Clydesdale™ Spinal System | ||
| Clydesdale PTC™ Spinal System | ||
| Cornerstone™ PSR Cervical Fusion System | ||
| Crescent™ Spinal System | ||
| Crescent™ Spinal System Titanium | ||
| Divergence-L™ Anterior/Oblique Lumbar Fusion System | ||
| Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only) | ||
| Elevate™ Spinal System | ||
| Perimeter Interbody Fusion Device | ||
| Pivox™ Oblique Lateral Spinal System | ||
| Sovereign™ Spinal System | ||
| T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) | ||
| Classification Names | Intervertebral Fusion Device with Bone Graft, Lumbar | |
| Intervertebral Fusion Device with Integrated Fixation, Lumbar | ||
| Spinal Vertebral Body Replacement Device | ||
| Intervertebral Fusion Device with Bone Graft, Cervical | ||
| Intervertebral Fusion Device with Integrated Fixation, Cervical | ||
| Regulatory | ||
| Class | Class II | |
| Regulation | ||
| Number | 888.3080; 888.3060 | |
| Regulation | ||
| Name | Intervertebral Body Fusion Device; Spinal Intervertebral Body Fixation Orthosis | |
| Device | ||
| Product | ||
| Classification Code | MAX; OVD; MQP; PLR; ODP; OVE | |
| Predicate | ||
| Devices | Primary Predicate: | |
| ARTIC-L™ 3D and ARTIC-XL™ 3D Ti Spinal System with | ||
| TiONIC™ Technology K190959 (S.E. 07/03/2019) | ||
| Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | K192018 (S.E. 08/16/2019) | |
| Additional Predicates: | ||
| ANATOMIC PEEK™ Cervical Fusion System | K112444 (S.E. 11/15/2011); | |
| K122037 (S.E. 03/22/2013); | ||
| K130177 (S.E. 09/23/2013) | ||
| ANATOMIC PEEK™ PTC Cervical Fusion Spinal System | K133653 (S.E. 04/28/2014); | |
| K160528 (S.E. 03/28/2016) | ||
| Capstone™ Spinal System | K073291 (S.E. 04/24/2008); | |
| K103731 (S.E. 07/18/2011); | ||
| K121760 (S.E. 08/29/2012); | ||
| K123978 (S.E. 04/09/2013); | ||
| K133650 (S.E. 12/20/2013); | ||
| K151128 (S.E. 08/06/2015) | ||
| Capstone Control™ Spinal System | K120368 (S.E. 04/09/2012); | |
| K171107 (S.E. 09/26/2017); | ||
| K190165 (S.E. 05/06/2019) | ||
| Capstone Control PTC™ Spinal System | K171107 (S.E. 09/26/2017) | |
| Capstone PTC™ Spinal System | K133205 (S.E. 03/12/2014); | |
| K172199 (S.E. 09/19/2017) | ||
| Clydesdale™ Spinal System | K083026 (S.E. 12/29/2008); | |
| K100175 (S.E. 06/02/2010); | ||
| K112405 (S.E. 11/21/2011); | ||
| K113528 (S.E. 12/20/2011); | ||
| K132897 (S.E. 12/11/2013); | ||
| K151128 (S.E. 08/06/2015) | ||
| Clydesdale PTC™ Spinal System | K133205 (S.E. 03/13/2014) | |
| Cornerstone™ PSR Cervical Fusion System | K100214 (S.E. 06/25/2010); | |
| K111264 (S.E. 10/12/2011); | ||
| K122037 (S.E. 03/22/2013); | ||
| K153373 (S.E. 01/19/2016) | ||
| Crescent™ Spinal System | K172199 (S.E. 09/19/2017); | |
| K171031 (S.E. 07/06/2017); | ||
| K133216 (S.E. 11/22/2013); | ||
| K094025 (S.E. 04/26/2010) | ||
| Crescent™ Spinal System Titanium | K172199 (S.E. 09/19/2017); | |
| K110543 (S.E. 08/09/2011) | ||
| Divergence-LT™ Anterior/Oblique Lumbar Fusion System | K162212 (S.E. 05/19/2017); | |
| K150135 (S.E. 06/11/2015) | ||
| Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only) | K142450 (S.E. 10/01/2014); | |
| K141599 (S.E. 01/21/2015); | ||
| K182885 (S.E. 02/06/2019) | ||
| Elevate™ Spinal System | K142559 (S.E. 06/09/2015); | |
| K172199 (S.E. 09/19/2017) | ||
| Perimeter Interbody Fusion Device | K090353 (S.E. 09/29/2009); | |
| K113642 (S.E. 02/06/2012); | ||
| K131669 (S.E. 11/01/2013); | ||
| K132700 (S.E. 09/26/2013); | ||
| K133645 (S.E. 01/03/2014); | ||
| K160418 (S.E. 03/07/2016) | ||
| Pivox™ Oblique Lateral Spinal System | ||
| Sovereign™ Spinal System | ||
| T2 Stratosphere™ Expandable Corpectomy System (Cervical | ||
| and Thoracolumbar) | K152277 (S.E. 11/13/2015) | |
| K091813 (S.E. 11/17/2009); | ||
| K121982 (S.E. 07/26/2012); | ||
| K162680 (S.E. 12/14/2016); | ||
| K172328 (S.E. 11/02/2017) | ||
| K173125 (S.E. 12/20/2017); | ||
| K181328 (S.E. 09/19/2018); | ||
| K183510 (S.E. 01/16/2019) | ||
| These predicate devices have not been subject to a design related recall | ||
| Description | ||
| of Device | ||
| ANATOMIC | ||
| PEEK™ Cervical | ||
| Fusion System | The ANATOMIC PEEK Cervical Fusion System consists of cages of | |
| various widths and heights which can be inserted betweentwo cervical | ||
| vertebral bodies to give support and correction during cervical interbody | ||
| fusion surgeries. The hollow geometry of the implants allows them to be | ||
| packed with autogenous bone and/or allograft bone graft comprised of | ||
| cancellous and/or corticocancellous bone graft, and/or demineralized | ||
| allograft bone with bone marrow aspirate. The ANATOMIC PEEK | ||
| devices must be used with supplemental fixation. | ||
| ANATOMIC | ||
| PEEK™ PTC | ||
| Cervical Fusion | ||
| Spinal System | The ANATOMIC PEEK™ PTC Cervical Fusion System consists of cages | |
| of various widths and heights which can be inserted betweentwo cervical | ||
| vertebral bodies to give support and correction during cervical interbody | ||
| fusion surgeries. The hollow geometry of the implants allows them to be | ||
| packed with autogenous bone and/or allograft bone graft comprised of | ||
| cancellous and/or corticocancellous bone graft, and/or demineralized | ||
| allograft bone with bone marrow aspirate. The ANATOMIC PEEK™ | ||
| PTC devices must be used with supplemental fixation. | ||
| Capstone™ Spinal | ||
| System | The CAPSTONE™ Spinal System consists of PEEK cages, titanium alloy | |
| cages, and titanium cages of various widths and heights, which canbe | ||
| inserted between two lumbar or lumbosacral vertebral bodies to give | ||
| support and correction during lumbar interbody fusion surgeries. The | ||
| hollow geometry of the implants allows them to be packed with | ||
| autogenous bone and/or allograft bone graft comprised of cancellous | ||
| and/or corticocancellous bone graft, and/or demineralized allograft | ||
| bone with bone marrow aspirate. | ||
| Capstone Control™ | ||
| Spinal System | The CAPSTONE CONTROL™ Spinal System consists of PEEK cages of | |
| various widths and heights, which can be inserted between two lumbar or | ||
| lumbosacral vertebral bodies to give support and correction during lumbar | ||
| interbody fusion surgeries. The hollow geometry of the implants allows | ||
| them to be packed with autogenous bone and/or allograft bone graft | ||
| comprised of cancellous and/or corticocancellous bone graft, and/or | ||
| demineralized allograft bone with bone marrow aspirate. See the MDT | ||
| Catalog or price list for further information about warranties and | ||
| limitations of liability. | ||
| Capstone Control | ||
| PTCTM Spinal | ||
| System | The CAPSTONE CONTROL PTC™ Spinal System consists of | |
| commercially pure titanium (CP Ti) coated PEEK cages ofvarious widths | ||
| and heights, which can be inserted between two lumbar or lumbosacral | ||
| vertebral bodies to give support and correction during lumbar interbody | ||
| fusion surgeries. The hollow geometry of the implants allows them to be | ||
| packed autogenous bone and/or allograft bone graft comprised of | ||
| cancellous and/or corticocancellous bone graft, and/or demineralized | ||
| allograft bone with bone marrow aspirate. | ||
| Capstone PTCTM | ||
| Spinal System | The CAPSTONE PTCTM Spinal System consists of commercially pure | |
| titanium (CP Ti) coated PEEK cages of various widths and heights, which | ||
| can be inserted between two lumbar or lumbosacral vertebral bodies to give | ||
| support and correction during lumbar interbody fusion surgeries. The | ||
| hollow geometry of the implants allows them to be packed with | ||
| autogenous bone and/or allograft bone graft comprised of cancellous | ||
| and/or corticocancellous bone graft, and/or demineralized allograft | ||
| bone with bone marrow aspirate. | ||
| Clydesdale™ Spinal | ||
| System | The CLYDESDALE® Spinal System consists of PEEK cages of various | |
| widths and heights, which include Tantalum markers. These devices can be | ||
| inserted between two lumbar or lumbosacral vertebral bodies to give | ||
| support and correction during lumbar interbody fusion surgeries. The | ||
| hollow geometry of the implants allows them to be packed with | ||
| autogenous bone and/or allograft bone graft comprised of cancellous | ||
| and/or corticocancellous bone graft, and/or demineralized allograft | ||
| bone with bone marrow aspirate. | ||
| Clydesdale™ Spinal | ||
| System (w/Infuse) | The CLYDESDALE® Spinal System consists of PEEK cages of various | |
| widths and heights, which include Tantalum markers. These devices can be | ||
| inserted between two lumbar or lumbosacral vertebral bodies to give | ||
| support and correction during lumbar interbody fusion surgeries. The | ||
| hollow geometry of the implants allows them to be packed autogenous | ||
| bone and/or allograft bone graft comprised of cancellous and/or | ||
| corticocancellous bone graft, and/or demineralized allograft bone with | ||
| bone marrow aspirate, or INFUSE® Bone Graft as designated below. | ||
| Clydesdale PTCTM | ||
| Spinal System | The CLYDESDALE PTCTM Spinal System consists of commercially pure | |
| titanium (CP Ti) coated PEEK cages of various widths and heights, which | ||
| include tantalum markers. These devices can be inserted between two | ||
| lumbar or lumbosacral vertebral bodies to give support and correction | ||
| during lumbar interbody fusion surgeries. The hollow geometry of the | ||
| implants allows them to be packed with autogenous bone and/or allograft | ||
| bone graft comprised of cancellous and/or corticocancellous bone | ||
| graft, and/or demineralized allograft bone with bone marrow aspirate. | ||
| Cornerstone™ PSR | ||
| Cervical Fusion | ||
| System | The CORNERSTONE® PSR Cervical Fusion System consists of cages of | |
| various widths and heights, which can be inserted between two cervical | ||
| vertebral bodies to give support and correction during cervical interbody | ||
| fusion surgeries. The hollow geometry of the implants allows them to be | ||
| packed with autogenous bone and/or allograft bone graft comprised of | ||
| cancellous and/or corticocancellous bone graft, and/or demineralized | ||
| allograft bone with bone marrow aspirate in cervical fusion procedures. | ||
| The CORNERSTONE® PSR device is to be used with supplemental | ||
| instrumentation and is to be implanted via an open, anterior approach. See | ||
| the MDT Catalog or price list for further information about warranties and | ||
| limitations of liability. | ||
| Crescent™ Spinal | ||
| System | The CRESCENT® Spinal System consists of PEEK cages of various | |
| widths and heights which can be inserted between two lumbar or | ||
| lumbosacral vertebral bodies to give support and correction during lumbar | ||
| interbody fusion surgeries. The hollow geometry of the implants allows | ||
| them to be packed with autogenous bone and/or allograft bone graft | ||
| comprised of cancellous and/or corticocancellous bone graft, and/or | ||
| demineralized allograft bone with bone marrow aspirate. The implants | ||
| may be implanted via a posterior, transforaminal or lateral approach and | ||
| the procedure may be open or minimally invasive. See the MDT Catalog or | ||
| price list for further information about warranties and limitations of | ||
| liability. | ||
| CrescentTM Spinal | ||
| System Titanium | The CRESCENT® Spinal System Titanium consists of implant grade titanium | |
| alloy (Ti-6Al-4V) cages of various widths and heights which can be inserted | ||
| between two lumbar or lumbosacral vertebral bodies to give support and | ||
| correction during lumbar interbody fusion surgeries. The hollow geometry of | ||
| the implants allows them to be packed with autogenous bone and/or allograft | ||
| bone graft comprised of cancellous and/or corticocancellous bone graft, | ||
| and/or demineralized allograft bone with bone marrow aspirate. The | ||
| implants may be implanted via a transforaminal or lateral approach and the | ||
| procedure may be open or minimally invasive. | ||
| Divergence-LTM | ||
| Anterior/Oblique | ||
| Lumbar Fusion | ||
| System | The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System consists of | |
| plates, bone screws, and interbody cages. The DIVERGENCE-LTM | ||
| Anterior/Oblique Lumbar Fusion System plates and bone screws are available in | ||
| a broad range of size offerings intended for anterior screw fixation and | ||
| stabilization during the normal healing process following surgical correction of | ||
| disorders of the spine. Fixation is provided by bone screws inserted into the | ||
| vertebral body of the lumbar spine using an anterior or oblique approach. The | ||
| DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System plate and bone | ||
| screws are made from titanium alloy and are provided sterile. Additionally, the | ||
| DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody cages | ||
| may be used as supplemental fixation when used in conjunction with posterior | ||
| fixation devices to treat deformity conditions in the thoracic and lumbar spine. | ||
| The hollow geometry of the implants allows them to be packed with autogenous | ||
| bone and/or allograft bone graft comprised of cancellous and/or | ||
| corticocancellous bone graft, and/or demineralized allograft bone with bone | ||
| marrow aspirate or INFUSETM Bone Graft (as designated below). The cages | ||
| are manufactured from medical grade polyetheretherketone (PEEK) and titanium | ||
| alloy with tantalum markers and are provided sterile. | ||
| Divergence™ | ||
| Anterior Cervical | ||
| Fusion System | ||
| (For Stand-Alone | ||
| Interbody Device | ||
| Only) | The DIVERGENCET™ Anterior Cervical Fusion System is an intervertebral | |
| body fusion device with internal screw fixation. The system is comprised of an | ||
| interbody cage and bone screws. These implants are for single use only. The | ||
| DIVERGENCET™ anterior cervical cages are provided in 0 and 6 degrees of | ||
| lordosis, 5-12mm heights, 15-20mm widths and 12- 16mm depths. This device is | ||
| intended to be radiolucent, and the interior space of the product is to be used | ||
| with autogenous bone and/or allograft bone graft comprised of cancellous | ||
| and/or corticocancellous bone graft, and/or demineralized allograft bone | ||
| with bone marrow aspirate . The DIVERGENCET™ stand-alone cervical | ||
| interbody device is manufactured from medical grade polyetheretherketone | ||
| (PEEK) and contains radiopaque markers made from medical grade titanium | ||
| alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, | ||
| built- in rotary locking mechanism. The bone screws used with this device are | ||
| provided in self-drilling and self-tapping options and are manufactured from | ||
| medical grade titanium alloy. The bone screws are provided in 3.5mm and | ||
| 4.0mm diameters and 9-17mm lengths. The PEEK material used conforms to | ||
| ASTM F2026 and the titanium alloy material used conformsto ASTM F136. To | ||
| achieve best results, do not use any of the DIVERGENCETM™ Anterior Cervical | ||
| Fusion System implant components with components from any other system or | ||
| manufacturer unless specifically allowed to do so in this or another Medtronic | ||
| document. As with all orthopaedic and neurosurgical implants, none of the | ||
| DIVERGENCETM Anterior Cervical Fusion System components should ever be | ||
| reused under any circumstances. | ||
| Elevate™ Spinal | ||
| System | The ELEVATET™ Spinal System is an expandable PEEK, Tantalum, and | |
| Titanium alloy interbody device consisting of various lengths and starting | ||
| heights, which can be inserted between two lumbar or lumbosacral vertebral | ||
| bodies to give support and correction during lumbar interbody fusion surgeries. | ||
| The ELEVATET™ Spinal System expands for adjustable lordosis and height to | ||
| match patient anatomy. The hollow geometry of the implants allows them to be | ||
| packed with autogenous bone and/or allograft bone graft comprised of | ||
| cancellous and/or corticocancellous bone graft, and/or demineralized | ||
| allograft bone with bone marrow aspirate . The implants may be implanted via | ||
| a posterior or transforaminal approach and the procedure may be open or | ||
| minimally invasive. The ELEVATET™ Spinal System can be implanted | ||
| unilaterally and bilaterally. The ELEVATET™ Spinal System is intended to be | ||
| inserted with ELEVATET™ Spinal System reusable instruments. ELEVATETM | ||
| Spinal System implants are for single use only. | ||
| Perimeter Interbody | ||
| Fusion Device | The PERIMETER® Interbody Fusion Device consists of cages of various | |
| widths and heights which can be inserted between two lumbar or lumbosacral | ||
| vertebral bodies to give support and correction during lumbar interbody fusion | ||
| surgeries. The hollow geometry of the implants allows them to be packed with | ||
| autogenous bone and/or allograft bone graft comprised of cancellous | ||
| and/or corticocancellous bone graft, and/or demineralized allograft bone | ||
| with bone marrow aspirate . The PERIMETER® Interbody Device is to be | ||
| used with supplemental fixation instrumentation. The device is offered in | ||
| Titanium Alloy (Titanium- 6Aluminum-4Vanadium ELI) or PEEK | ||
| (Polyetheretherketone). This interbody device is offered in sterile or non-sterile | ||
| forms. Refer to the package label for specific implant sterility information. The | ||
| PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging | ||
| from 8mm to 20mm in height, 15mm to 28mm in length, and between 19mm | ||
| and 38mm in width. An array of lordosis options are |
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provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Allov (Titanium-6Aluminum- 4Vanadium ELI) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. Medical grade titanium, titanium alloy, and/or medical grade cobalt- chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy with stainless steel in the same construct. PEEK implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants. See the MDT Catalog or price list for further information about warranties and limitations of liability. Perimeter Interbody The PERIMETER® Interbody Fusion Device consists of cages of various Fusion Device widths and heights which can be inserted between two lumbar or lumbosacral (w/Infuse) vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with either autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or INFUSE® Bone Graft as designated below. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum- 4Vanadium ELI) or PEEK (Polyetheretherketone). However, only the PEEK device is approved for use with INFUSE® Bone Graft. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for approved PEEK PERIMETER® implant sizes. This interbody device is offered in sterile or non- sterile forms. Refer to the package label for specific implant sterility information. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum- 4Vanadium ELI) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
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| Pivox™ Oblique
Lateral Spinal
System | The PIVOX™ Oblique Lateral Spinal System consists of interbody cages,
plates, and bone screws. The PIVOX™ Oblique Lateral Spinal System
interbody cages are available in various widths, heights, and lordosis inserted
between two lumbar vertebral bodies to give support and correction during
lumbar interbody fusion surgeries. The hollow geometry of the implants allows
them to be packed with autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate, or INFUSE™
Bone Graft (as designated below) and must be used with supplemental fixation.
The cages are manufactured frommedical grade polyetheretherketone (PEEK)
and titanium alloy with tantalum markers and are provided sterile. The
PIVOX™ Oblique Lateral Spinal System plates and bone screws are available
in a broad range of sizes intended for anterior column screw fixation and
stabilization during the normal healing process following surgical correction of
disorders of the spine. Fixation is provided by bone screws inserted into the
vertebral body of the lumbar spine using an anterior, lateral, or oblique
approach. The PIVOX™ Oblique Lateral Spinal System plate and bone screws
are made from titanium alloy and are provided sterile. | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| Sovereign™ Spinal
System | The SOVEREIGN™ Spinal System is an intervertebral body fusion device
with internal screw fixation. The screws protrude through the interbody portion
of the device and stabilize the vertebral body while preventing expulsion of the
implant. The implant is lens-shaped with 3 holes for placement of titanium
screws using an anterior or oblique approach. The SOVEREIGN™ Spinal
System contains both a fixed and a variable angle screw option. The fixed
angle screw option provides an interference fit with the polyetheretherketone
(PEEK) interbody implant. The variable angle screw option provides a slight
clearance between the PEEK interbody implant and the screw which allows for
a small amount of variable screw angulation. This system is intended to be
radiolucent and the interior space of the product is to be used with autogenous
bone and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate. The accompanying cover plate is designed to resist
screw backout and must be used when the variable angle screws are implanted.
The SOVEREIGN™ Spinal System interbody device is manufactured from
PEEK (polyetheretherketone) and contains tantalum radiopaque markers. The
screws used with this device are manufactured from titanium alloy. | |
| T2 Stratosphere™
Expandable
Corpectomy System
(Cervical and
Thoracolumbar) | The T2 Stratosphere™ Expandable Corpectomy System is an adjustable
vertebral body replacement device and features a self- adjusting end cap which
provides continuous angulation between 0-8° in any direction to accommodate
the patient's anatomical requirements. T2 Stratosphere™ Expandable
Corpectomy System devices for use in the thoracolumbar and cervical spine
are restricted to the 13mm diameter centerpieces. The T2 Stratosphere™
Expandable Corpectomy System is made of titanium alloy and is provided
sterile and non-sterile. This device is inserted between two vertebral bodies in
the thoracolumbar or cervical spine and is expanded to aid in the surgical
correction and stabilization of the spine. The centerpieces are available in
multiple heights. The system also features modular end caps which are
available in various angles and diameters and are only for use in the
thoracolumbar spine. The device is not intended to be used as a stand-alone
implant. | |
| | No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular
purpose or use are specifically excluded. | |
| | | Never use titanium or titanium alloy implants with stainless steel in the same construct. |
| Indications
for Use: | ANATOMIC
PEEKTM Cervical
Fusion System | The ANATOMIC PEEK Cervical Fusion System is indicated for cervical interbody
fusion procedures in skeletally mature patients with cervical disc disease at one level
from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable
radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on
posterior vertebral endplates producing symptomatic nerve root and/or spinal cord
compression confirmed by radiographic studies. This device is to be used in patients
who have had six weeks of non-operative treatment. The ANATOMIC PEEK device
is to be used with supplemental fixation. The ANATOMIC PEEK Cervical Fusion
System is also required to be used with autogenous bone and/or allograft bone
graft comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate and is to be implanted
via an open anterior approach. |
| | ANATOMIC
PEEKTM PTC
Cervical Fusion
Spinal System | The ANATOMIC PEEK PTC Cervical Fusion System is indicated for use in skeletally
mature patients with degenerative disc disease (DDD) of the cervical spine with
accompanying radicular symptoms at atone disc level or two contiguous levels. DDD
is defined as discogenic pain with degeneration of the disc confirmed by patent history
and radiographic studies. The ANATOMIC PEEK PTC Cervical Fusion System is
used to facilitate intervertebral body fusion in the cervical spine and is placed via an
anterior approach from the C2-C3 disc space to the C7-T1 disc space using
autogenous bone and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone graft, and/or demineralized allograft bone with bone
marrow aspirate. The ANATOMIC PEEK PTC Cervical Fusion System is to be used
with supplemental fication. Patients should have at least six weeks of non-operative
treatment prior to treatment with an intervertebral cage. |
| | CapstoneTM Spinal
System | The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures
for patients diagnosed with Degenerative Disc Disease (DDD) at one or two
contiguous levels from L2 to S1. DDD patients may also have up to Grade 1
Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as
discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. When used for these indications, the CAPSTONE® Spinal
System is intended for use with supplemental fixation systems cleared for use in the
lumbar spine.
Additionally, the CAPSTONE® Spinal System can be used to provide anterior
column support in patients diagnosed with degenerative scoliosis as an adjunct to
pedicle screw fixation. These patients should be skeletally mature and have had six
months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be
used with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate when the subject device is used as an adjunct to fusion. These
implants may be implanted via an open or a minimally invasive posterior approach.
Alternatively, these implants may also be implanted via an anterior and/or
transforaminal approach. |
| Capstone Control™
Spinal System | The Capstone Control™ Spinal System is intended to be used in spinal fusion
procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2
contiguous levels from L2 to S1. DDD patients may also have up to Grade 1
spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic
back pain with degeneration of the disc confirmed by history and radiographic studies.
When used for these indications, the Capstone Control™ Spinal System is intended
for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the Capstone Control™ Spinal System can be used to provide anterior
column support in patients diagnosed with degenerative scoliosis as an adjunct to
pedicle screw fixation. These patients should be skeletally mature and have had 6
months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of2 implants are required per spinal level. | |
| Capstone Control
PTC™ Spinal
System | The CAPSTONE CONTROL PTC™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL PTC™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE CONTROL PTC™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL PTC™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. | |
| | | |
| Capstone PTCTM
Spinal System | The CAPSTONE PTC™ Spinal System is indicated for interbody fusion in patients
with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These
DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the
involved levels. DDD isdefined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies. These patients should be skeletally
mature and have had six months of non-operative treatment. Additionally, the
CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal
deformity as a supplement to pedicle screw fixation in patients diagnosed with
degenerative scoliosis. These implants may be implanted via an open or a minimally
invasive posterior approach. Alternatively, these implants may also be implanted via
an anterior and/or transforaminal approach. These implants are to be used with
autogenous bone and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone graft, and/or demineralized allograft bone with bone
marrow aspirate. These devices are intended to be used with supplemental fixation
instrumentation, which has been cleared by the Food and Drug Administration (FDA)
for use in the lumbar spine. | |
| Clydesdale™ Spinal
System | The CLYDESDALE® Spinal System is designed to be used with autogenous bone
and/or allograft bone graft comprised of cancellous and/or corticocancellous
bone graft, and/or demineralized allograft bone with bone marrow aspirate to
facilitate interbody fusion and is intended for use with supplemental fixation systems
cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for
patients diagnosed with degenerative disc disease (DDD) at one or two contiguous
levels from L2 to S1. These DDD patients may also have up to Grade 1
Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic
back pain with degeneration of the disc confirmed by history and radiographic studies.
These patients should be skeletally mature and have had six months of non-operative
treatment. These implants may be implanted via a minimally invasive lateral
approach. | |
| Clydesdale™ Spinal
System (w/ Infuse) | The CLYDESDALE® Spinal System is intended to be used in interbody fusion
procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or
two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1
Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as
discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. When used for these indications, the CLYDESDALE® Spinal
System is intended for use with supplemental fixation systems cleared for use in the
lumbar spine.
Certain sizes of the CLYDESDALE® Spinal System may be used with INFUSE®
Bone Graft in single-level Oblique Lateral Interbody Fusion (OLIF) procedures from
L2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling for
the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for information on the
specific sizes of the CLYDESDALE® Spinal System approved for use with
INFUSE® Bone Graft, as well as specific information regarding contraindications,
warnings, and precautions associated with INFUSE® Bone Graft. INFUSE® Bone
Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical
approach.
Additionally, the CLYDESDALE® Spinal System can be used to provide anterior
column support in patients diagnosed with degenerative scoliosis as an adjunct to
pedicle screw fixation. INFUSE® Bone Graft is not indicated for use in patients with
this condition.
These patients should be skeletally mature and have had six months of nonoperative
treatment. The CLYDESDALE® Spinal System is intended | |
| | | |
| | to be used with autogenous bone and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone graft, and/or demineralized allograft
bone with bone marrow aspirate when the subject device is used as an adjunct to
fusion. These implants may be implanted via a minimally invasive lateral approach. | |
| Clydesdale PTCTM
Spinal System | The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous
bone and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone graft, and/or demineralized allograft bone with bone
marrow aspirate to facilitate interbody fusion and is intended for use with
supplemental fixation systems cleared for use in the lumbar spine. The
CLYDESDALE PTC™ Spinal System is used for patients diagnosed with
Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1.
These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at
the involved levels. DDD is defined as discogenic back pain with degeneration of the
disc confirmed by history and radiographic studies. These patients should be skeletally
mature and have had six months of non-operative treatment. These implants may be
implanted via a minimally invasive lateral approach. | |
| Cornerstone™ PSR
Cervical Fusion
System | The CORNERSTONE® PSR device is indicated for cervical interbody fusion
procedures in skeletally mature patients with cervical disc disease at one level from
the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable
radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on
posterior vertebral endplates producing symptomatic nerve root and/or spinal cord
compression confirmed by radiographic studies. This device is to be used in patients
who have had six weeks of non-operative treatment. The CORNERSTONE® PSR
device is to be used with supplemental fixation. The CORNERSTONE® PSR device
is also required to be used with autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate and is to be implanted via
an open, anterior approach. | |
| Crescent™ Spinal
System | The CRESCENT™ Spinal System is indicated for interbody fusion in patients with
Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD
patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved
levels. DDD is defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies. These patients should be skeletally
mature and have had six months of non-operative treatment. These implants are to be
used with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate . These devices are intended to be used with supplemental
fixation instrumentation which has been cleared by the FDA for use in the lumbar
spine. | |
| | | |
| Crescent™ Spinal
System Titanium | The CRESCENT™ Spinal System Titanium is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine. | |
| Divergence-LTM
Anterior/Oblique
Lumbar Fusion
System | The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 (except as defined for use with INFUSETM Bone Graft above). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. Certain sizes of the Certain sizes of the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSETM Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended for use with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine when used to treat DDD. Consult the labeling for the INFUSETM Bone Graft/Medtronic Interbody Fusion Device for additional information on the | |
| Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only) | specific sizes of the DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System Interbody device approved for use with INFUSET™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSET™ Bone Graft. DIVERGENCE-L Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSET™ Bone Graft. The DIVERGENCET™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCETM stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCET™ stand-alone cervical interbody device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non- fusion spinal surgery at involved level may be treated with the device. | |
| Elevate™ Spinal System | The ELEVATET™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine. | |
| Perimeter Interbody Fusion Device | The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. | |
| Perimeter Interbody
Fusion Device (w/
Infuse) | The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with
autogenous bone and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone graft, and/or demineralized allograft bone with bone
marrow aspirate in patients with degenerative disc disease (DDD) at one or two
contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1
Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as
discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. These patients should be skeletally mature and have had six
months of non-operative treatment. These implants may be implanted via a variety of
open or minimally invasive approaches. These approaches include anterior, lateral,
and oblique. These devices are intended to be used with supplemental fixation
instrumentation, which has been cleared for use in the lumbar spine.
Certain sizes of the PEEK PERIMETER® Interbody Fusion Device may also be used
with INFUSE® Bone Graft for patients diagnosed with DDD, as defined above. The
device may be implanted at a single level using an Anterior Lumbar Interbody Fusion
(ALIF) approach from L2-S1. The device may also be implanted at a single level
using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The
PEEK PERIMETER® Interbody Fusion Device should be used with supplemental
fixation systems cleared for use in the lumbar spine. Consult the labeling for the
| |
| Pivox™ Oblique
Lateral Spinal
System | The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used
with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate to facilitate interbody fusion and is intended for use with
supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™
Oblique Lateral Spinal System interbody cage is used for patients diagnosed with
degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved levels. DDD is defined as discogenic back pain with degeneration of the
disc confirmed by history and radiographic studies.
Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide
anterior column support in patients diagnosed with degenerative scoliosis as an
adjunct to pedicle screw fixation. These patients should be skeletally mature and
have had six months of non- operative treatment.
These implants may be implanted via a minimally invasive or open lateral or oblique
approach. Certain sizes of the PIVOX™ Oblique Lateral Spinal System Interbody
Cage may also be used with INFUSE™ Bone Graft for patients diagnosed with
DDD, as defined above, who are skeletally mature and have had six months of non-
operative treatment. The device may be implanted at a single level using an Oblique
Lateral Interbody Fusion (OLIF) approach from L2- L5 and is intended for use with
supplemental fixation systems cleared for use in the lumbar spine. Consult the
labeling for the INFUSE™ Bone Graft/ Medtronic Interbody Fusion Device for
information on the specific sizes of the PIVOX™ Oblique Lateral Spinal System
Interbody Cage approved for use with INFUSE™ Bone Graft, as well as specific
information regarding contraindications, warnings, and precautions associated with
INFUSE™ Bone Graft. INFUSE™ Bone Graft | |
| | is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach.
Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide
anterior column support in patients diagnosed with degenerative scoliosis as an
adjunct to pedicle screw fixation. These patients should be skeletally mature and
have had six months of non-operative treatment. These implants may be implanted
via a minimally invasive or open lateral or oblique approach. INFUSE™ Bone Graft
is not indicated for use in patients with this condition. The PIVOX™ Oblique Lateral
Spinal System plate and bone screw components are indicated as a supplemental
fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of
the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the
vascular structures. The indications and contraindications of spinal instrumentation
systems should be understood by the surgeon. The plate and bone screw components
are indicated for use in the temporary stabilization of the anterior lumbar spine
during the development of spinal fusions in patients with: 1) DDD defined by back
pain of discogenic origin with degeneration of the disc confirmed by patient history
and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity
defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed
previous fusions. When used together, the PIVOX™ Oblique Lateral Spinal System
components can be used to treat patients with DDD at one or two contiguous levels
from L2 to S1 (except as defined for use with INFUSE™ Bone Graft above). These
DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved levels. | |
| Sovereign™ Spinal
System | The SOVEREIGN™ Spinal System is indicated for use with autogenous bone
graft and/or allograft bone graft comprised on cancellous and/or
corticocancellous bone graft, and/or demineralized allograft bone with bone
marrow aspirate in patients with degenerative disc disease (DDD) at one or two
contiguous levels from L2 to S1. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. Additionally,
the SOVEREIGN™ Spinal System is indicated for use in patients diagnosed with
multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to
fusion. These patients should be skeletally mature and have had 6 months of non-
operative treatment. When used in patients as an adjunct to fusion in patients
diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions,
additional supplemental fixation (e.g. posterior fixation) must be used. These
implants may be implanted via a variety of open or minimally invasive approaches.
These approaches include anterior and oblique. The SOVEREIGN™ interbody
system may be used as a stand-alone device or in conjunction with supplemental
fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is
intended to be used with 3 titanium alloy fixed or variable angle screws.
The accompanying cover plate MUST be used anytime the device is used with any
number of variable angle screws. If the physician chooses to use less than 3 or none
of the provided screws, additional supplemental fixation in the lumbar spine must be
used to augment stability. Implants with lordosis angles greater than 18° are intended
to be used with supplemental fixation (e.g. facet screws or posterior fixation). | |
| T2 Stratosphere™
Expandable
Corpectomy System
(Cervical and
Thoracolumbar) | The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body
replacement device intended for use in the thoracic and lumbar spine (T1-L5) and
cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is
intended for use in skeletally mature patients. When used in the cervical spine, the T2
Stratosphere™ Expandable Corpectomy System is used to replace a collapsed,
damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or
osteomyelitis, or for reconstruction following corpectomy performed to achieve
decompression of the spinal cord and neural tissues in cervical degenerative
disorders. | |
| When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy
System may not be used with optional modular end caps. When used in the cervical
spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System
is intended to be used with supplemental fixation for use in the cervical spine. When
used at more than two levels, supplemental fixation should include posterior fixation
cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the
T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed,
damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2
Stratosphere™ Expandable Corpectomy centerpiece may be used with or without
optional modular end caps which accommodate individual anatomic requirements.
The device is to be used with supplemental fixation cleared for use in the thoracic and
lumbar spine.
When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy
System is intended for use with autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate as an adjunct to fusion.
When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable
Corpectomy System is intended for use with autogenous bone and/or allograft
bone graft comprised of cancellous and/or corticocancellous bone graft, and/or
demineralized allograft bone with bone marrow aspirate as an adjunct to fusion.
The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore
the integrity of the spinal column even in the absence of fusion for a limited time in
patients with advanced stage tumors involving the cervical and/or thoracolumbar
spine in whom life expectancy is of insufficient duration to permit achievement of
fusion, with autogenous bone and/or allograft bone graft comprised of cancellous
and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate used at the surgeon's discretion. | | |
| Comparison of
Technological
Characteristic
s with the
Predicate
Devices | The modification for this Special 510(k) relates only to the indications for use. The intended use, material,
surgical technique, surface treatment, sterility, and design of the subject devices are the same as predicate
devices. The predicate and subject devices are intended for stabilization use and to promote bone fusion during
the normal healing process following surgical correction of disorders of the spine. The subject devices were
originally cleared for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone graft. The subject application provides published clinical outcomes to support the
use of demineralized allograft bone with bone marrow aspirate. | |
| Performance
Data | No performance testing was required or performed, as this modification for this Special 510(k) relates only to
the indications for use. | |
| | Biocompatibility
No new implants or instruments were included in this submission. | |
| | Mechanical Testing
No new mechanical testing was performed or required to support this application. | |
| | Design Validation
No new Design Validation testing was required as this submission does not include any new or modified
instruments or implants. A minor change was included in the surgical technique, but this only involves the
inclusion of demineralized allograft bone mixed with bone marrow aspirate and does not impact implant or
instrument design. | |
| | Clinical Outcomes
Clinical outcomes on the usage of demineralized allograft bone combined with bone marrow aspirate were
provided to support this application. | |
| Conclusion | Based upon the supporting documentation provided in the pre-market notification, the subject devices are safe
and effective as the primary predicates ARTIC-L™ 3D Ti Spinal System and the ARTIC- XL™ 3D Ti Spinal
System found in K190959 and Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS
Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody
Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device,
Endoskeleton TL Interbody Fusion Device – K192018, when demineralized allograft bone combined with bone
marrow aspirate is used. | |
11
12
13
14
T
15
16
17
18
19
20
21
| K192502 | |
|---|---|
| Page 1 of 21 | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | ANATOMIC PEEK™ Cervical Fusion System |
| Indications for Use (Describe) | The ANATOMIC PEEK Cervical Fusion System is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK Cervical Fusion System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open anterior approach. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
..
22
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | ANATOMIC PEEK TM PTC Cervical Fusion System |
| Indications for Use (Describe) | The ANATOMIC PEEK PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at atone disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patent history and radiographic studies. The ANATOMIC PEEK PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
23
| ਜੂੜ | 0479-E44 (10E) ຂອງທາງອະຊີ ຊຸດທາງຂອງສາຫຼາຍໃນປີ 2009 | ပြုပါ ခြင်ရှိ ရွာများ | (TIT) | |
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| dırım bəsonların və səmbəsov qolsul kurds ut bəsu əd ot bəbirəini si mərasın kimidə müharində əhli | of the successioning approses. | |||
| Indications for Use (Describe) | ||||
| Capitone™ Spinstem | ||||
| əmində əsinə q | ||||
| ប្រហូរ ប្រក្រ | ||||
| (1900) (Number (19) Kumoviy | ||||
| See PRA Staterent below | ||||
| 0202108190 Doster: 0 noiteniqxヨ | ndications for Use | |||
| Form Approved: ONB BMB. 0810-0120 | 2301V932 ИАМИН ОИА НТЈАЭН ЗО ТИЭМТЯАЧЭО | |||
| uoitersinimbA pung bus bood | ||||
| 17252502 | ||||
| I 2 to E 9869 | ||||
24
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| K192502 | Page 4 of 21 |
|---|---|
| Form Approved: OMB No. 0910-0120 | Expiration Date: 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | Capstone Control™ Spinal System |
| Indications for Use (Describe) | The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD patients may also have up to Grade 1spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Capstone Control™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had 6 months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
25
| K192502 | Page 5 of 21 |
|---|---|
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | Capstone Control PTC TM Spinal System |
| Indications for Use (Describe) | The CAPSTONE CONTROL PTC TM Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL PTC TM Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE CONTROL PTC TM Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL PTC TM Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
26
| K192502
| Page 6 of 21 | |
|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | Capstone PTCT™ Spinal System |
| Indications for Use (Describe) | The CAPSTONE PTCT™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE PTC™™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
27
| K192502
Page 7 of 21 | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. | Indications for Use |
| 510(k) Number (if known) | Unknown |
| Device Name | Clydesdale™ Spinal System |
| Indications for Use (Describe) | |
The CLYDESDALET™ Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with
Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to
Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the
CLYDESDALET™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar
spine. Certain sizes of the CLYDESDALET™ Spinal System may be used with INFUSET™ Bone Graft in single-level
Oblique Lateral Interbody Fusion (OLIF) procedures from L2 to L5 in patients diagnosed with DDD, as defined above.
Consult the labeling for the INFUSET™ Bone Graft/Medtronic Interbody Fusion Device for information on the specific
sizes of the CLYDESDALET™ Spinal System approved for use with INFUSET™ Bone Graft, as well as specific
information regarding contraindications, warnings, and precautions associated with INFUSET™ Bone Graft. INFUSET™
Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach. Additionally, the
CLYDESDALET™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative
coliosis as an adjunct to pedicle screw fixation. INFUSET™ Bone Graft is not indicated for use in patients with this
condition. These patients should be skeletally mature and have had six months of nonoperative treatment. The
CLYDESDALET™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the
subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| \ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
28
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | Clydesdale PTCT™ Spinal System |
| Indications for Use (Describe) | The CLYDESDALE PTCT™ Spinal System is designed to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTCT™Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants maybe implanted via a minimally invasive lateral approach. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)Page 1 of 1PSC Publishing Services (301) 443-6740EF
00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
29
| K192502
| Page 9 of 21 | |
|---|---|
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name | Cornerstone TM PSR Cervical Fusion System |
| Indications for Use (Describe) | The CORNERSTONE TM PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE TM PSR device is to be used with supplemental fixation. The CORNERSTONE TM PSR device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
30
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Page 10 of 21 | |
|---|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | ||
| See PRA Statement below. | ||
| 510(k) Number ( if known ) | Unknown | |
| Device Name | Crescent™ Spinal System | |
| Indications for Use (Describe) | The CRESCENT™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine. | |
| Type of Use (Select one or both, as applicable) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
205261 71
31
| | indications for Use | r və qalınmışdır. Azərbaycan filmləri və bayrağı və bayrağı və bayrağı və bayrağı və bayrağı və yarımızı və bayrağı və yarımızı və bayrağı və yarımızı və yarımızı və bayrağı
0202/08/08/08 09:18:00 noiteriax3 |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UMouxuՈ
510(k) Number (if known | | |
| Crescent™ Spinal System Titanium
Dəvicəs Name | | |
| .əniqs ısdımıl ədə ni əsn rol AQA ədə ən qalan qalan qalınmışdır.
undications for Use (Describe) | າເອອປ ຂອງ ແລະປະເທດໄທນາ ແບບໄຂການ ໄດ້ການສະໄໝປະ ວ່າກວາກອງM divi bezu ອຸປຸ ປີ ນອກການ ລາວ ຂອງເຈຍີ ອອກໄປ ລາວເກົ່າວຂອ
world in and thergolls bezilsranimes rolbus .flarg and suollesarsoning 10/bus suollesurs to berinquos
there and thersofils to but should think beau of on and of one studios and to situs and
xis bad əvan buran vilktələk əd birində əsərlər. Səibur əldərənibər bura vəsini və bəmilyan əsasən və
lo noiblərində yaxın ən baxı əsasən və bənilər si QQQ . slevəl bərlərin və sisəsilərlər. 10 sisəsiləlib. 10 sisəsilə ilə bir və qarının və qarının və qarının və qarının və q
əssəsib əsir əsrlərənə qalındırılır. 10 bərəsini 10 bəhsiləri ilə münatin mətrilə kənd. 1977-cü ildə 1972-cü ildə 197
I əbarə ol qu əvan osla vem sinəlir. İstinadlar | |
| | | |
| Type of Use (Select one or both, as applicable) | | |
| (0 กิธยุตบร 108 ภาว 12 กิธ9) อธน แม่เปิดที่วิทารอารา 2 | | (○ カレーム(1) 2008 月72 12) 02/11/2017 11/11/10/0 [ |
| | ДЭСЭЭЙ ЭГЭЭАЯ ЭТАЯАЧЭГ А ИО ЭЛИЛТИОЭ | |
| | . WOJER SSAREDA JIAMA ATATS ASS SHT OT MAO3 GATTJAMOS AUOY ONJE TON OGY
SEEL To to to to is not since and to stremerings of your selliges sin T | |
| | əyəldən bir bəhən ətəb ədə və bir çəkilər. Şərənov qey bir şəxs (suoisunun məliyəsi) və mü
ə qaran və qarın və əlamirə qəbul sini qurğuna sinə məsanət və qalındırılır. Bu mərkəzi və mərkəzi və mərkəzi və mərkəzi və mərkəzi və mə
:of ,nebrud sint published your suoitseppys pribuloni ,noitsello noitsmonni sinh to
əri gübuləni ,əsnoqsən ədən et bərənirə si noitəməlir. To noitəlilər sinfi növələr əldə ən mənilə ən mənist məbul ədə | |
| | vop.syy.repl@ggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggg
roitersisinimbA purq bus bood
ses on the more the stilled in the mineded
| |
| | to noticellos e 'o' buodear of beninpest on si nosted e business to toubuos you yem your of the
้างอิง | |
| (This) Institution | article spelling the starting of the starting of the starting of the starting of the starting of the state of the state of the seen the state of the state of the state of the | POC Publiching Services (101) 44 E-6 Pa
न च |
32
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
alications for Use
1930
מערב מיינוני 1900 מערים מערכת המושב המושב המושב המושב של המו məli məmələri və mərkəzi və bir və əs 0202/08/00 Dete: 06/2020
sinə aid bitki növü. İstinadlar Unknown
Device Mame
ນອງຂຽງ ແດ່ເຂົ້າ ຈາກປະມານ ລາວກັ່ງໄປ()ແດ່ນອກການ A ຜົນ 1-5 ວິທີອົງສາທຸດ
Indications for Use (Desscribe)
ni əsu 10 bərəb mərkəz noisu 1 ədən 1 əsrində əsasən "1-3-2013 09:10 əsr əsər və əsasən və əsasən və əsasən və əri . 18 ot 2 mort dəstəsinin fəsiləsini fəsiləsini fəsiləsində fəsiləsinin cinsinə aid bitk งเทพ จวเขอ จนใน อง ode bentled besongsib รับเทพ besougain อาหาร บางค์ พ.ศ. 2517 ประเทศ อว่างอย d bəniləb QQQ () :titiw streitsq in surəsində sahəsində ən qarının vərinə və və və və və və və vəsiləsilidir. r var de mi asu 10 batteribuil are surenoduco wars and pur state of T. ... 033115 at 11:24 am and bluest ın nəqo lo ylərini sinfi bəyan sinalqını əsərlər. Əlsilqza vorman ənəd diiw ənəd filmlərini və mərkəzi və bir və bir və bir və bir və bir və bir və bir və bir və bir və bir əd ol bəbrətiri si əsirəsi və qalını 1 ədən 1 əsrindən 1 əspild Onların 1 mil-20013091010 əsrin əvvələn əvvələn -non to sithom xis bar sed bluods streited จรรค์โ เทอเรนใ อา เวลานี้มี่เทดว งู่เพาะบิวรมที่ รัฐต่างๆ əində sənədlər bura yarımız əsir əhli in notirməsinə aid ələd əinə gəstə ən bəniləb si QQC . ələvəl мтЭЭЛЧИ Ийм эги юг рэппэр в төэхэ) 15 от 27 төгд гэсэг гэсэгт (ССС) эхлэг.) эгий гэсэг əridə redmul ədə il əsasən növünəmlərin növü. İstinadların daxil olunan və olan il bax sinə isə və və virində əməli və bilmələr Bone Graft. MIƏSUNI diye bəkində səsinə sayının sanınmışdır. 1991-ci ildə 1971-cü ildə 1972-cü ildə 2001-cü ildə 2001-cü ildə 2001-cü ildə 2001-cü ildə 2001-cü ildə 2001-cü ildə 2001-cü ənə məqsud virin əsri əsərlər ybodratırı mətsilə nəqrildiyinin əsasən və məlili Oxonanın məşğaların məşğ ənilədələrin illərdə .QQQ teatr ol bəzi nərin ən qal bərasın məd sat dəidir. ".o.itsinəmirləri insinəsinə i lshəməlqqıs diyiv əzu 101 bəbrətti si əsir ət mərkəndə əsərlərindən əsasən və MTT-30MƏDƏN 10 ışın sərinə bir . 12-21 mort dəstəsinin fəsiləsini fəsiləsinə aid bitki nəsl əlgari və başırıl ol ຽນປາສາກຳ ພາສາປີ ແລະນາ ແລະມີໄປປັບບ້ານການ ພາ ປະຊວມເວັດທີ ອປີ ໄດ້ ເອກະສາ ແລະເຈົ້າ ເມື່ອງ ເຂົ້າມີ ເປັນສາຫຼຸບ ກ່ອນໄດ້ ເປ ındır. (2011) 19:50 (2 isə 10 isinə çəsinə kimilər (1 ildə 1977-ci ildə 1977-ci ildə 1972-cü ildən 1971-ci ildə 1971-ci ildə 197 S : : seipurs singers bur your visu vd bemilinos said on noitersites of this misite ຣາເວລາ ເປນນັກການປະກວດ ເປນນັກລານປະຕິທິນເຕີຣາເນລາ ອາໄປ ເຂົ້າປາວມກາວ ການບວຂອງ ອປີ ໄດ້ (CJ-1 L) ແວ່ນຈາກນີໄດ້ əh əvods əupildə 10 ildə 10 sənədlər 10 (12-24) noitsəndid ədə 40 moled 10 illərdə 10 m əd 107 əsrinə məlumatı və sə bərcaibli ərə sinənqqına vəzəs ənod bir əsrlər mərkəzi və ildə və birin və birin və birin ronin M. J-30NGDXIVIQ ərtə əsasən və royanın əsasən əsərlər sənəsində əsasən və bir minim 10/011 .frerg and suollecurseouines to besinquos freig and thergolls and moregonis divin best bovloval จนี้ เธ รเรอปไรยได้รับปรุ่นที่อยู่ 1 จังหวัด of ตุม องธรรม อร์เธอ 200 จรรค์โว (จงอตร ทิรา) จากประ diri və qalında ni əsasəndən siləsinin mətvilə nəqlidovan məlumatı məlumatın məli bir nəsrlərindən mən ın növün yoqlarını ol bəbrəni si əgəs ybodəsini mərziya noizil ərqildənin məlumatı və 1-3-2019 NGC 117 ອກີ ໃດ ຂອງຂອງປີ 10 ກຸດ ກວ່າງສາກອີການປີ 1 ເມືອງການປະເທດໄທ ປະເທດສາຫາລະນະຄອນ ພາສາວິປາໄທລະວັງ ອາດສິນທາງປີ 10 ກິນ ປີ 100
Type of Use (Select one or port), as applicable
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io noticellos в до расоцентов гос гі поглед в рпв дологи по топлог топливодите на ". ເອປັນນາ BMO bilev ບຸກຄອນນວ ຄ.ສ. ເຊຍໄປຣib ໄດ້ ຂະອານາ ແດ່ງ່າຍຕາມປູແມ່
34
| K192502
| Page 14 of 21 | |
|---|---|
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
| Food and Drug Administration | |
| Indications for Use | |
| 510(k) Number (if known) | Unknown |
| Device Name | Divergence TM Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only) |
| Indications for Use (Describe) | The DIVERGENCE TM Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/orosteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE TM stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE TM stand-alone cervical interbody device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non- fusion spinal surgery at involved level may be treated with the device." |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740
EF |
| ---------------------- | ------------- | ---------------------------------------------- |
|---|
1944년 1월 1일 19일 10월 10일 10월 11일 10일 10월 11일 1
35
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |||
|---|---|---|---|
| Food and Drug Administration | |||
| Indications for Use | |||
| K192502 | Page 15 of 21 | ||
| Form Approved: OMB No. 0910-0120 | |||
| Expiration Date: 06/30/2020 | |||
| See PRA Statement below. | |||
| 510(k) Number ( if known ) | Unknown | ||
| Device Name | Elevate™ Spinal System | ||
| Indications for Use ( Describe ) | The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine. | ||
| Type of Use ( Select one or both, as applicable ) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |||
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |||
| Department of Health and Human Services | |||
| Food and Drug Administration | |||
| Office of Chief Information Officer | |||
| Paperwork Reduction Act (PRA) Staff | |||
| PRAStaff@fda.hhs.gov | |||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |||
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
ﺎﺑﺔ
36
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | K192502 |
|---|---|
| Food and Drug Administration | Page 16 of 21 |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | Unknown |
| Device Name | Perimeter Interbody Fusion Device |
| Indications for Use (Describe) | The PERIMETER Interbody Fusion Device is indicated for interbody fusion with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Certain sizes of the PEEK PERIMETER Interbody Fusion Device may also be used with INFUSET Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The PEEK PERIMETER Interbody Fusion Device should be used with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the INFUSET Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the PEEK PERIMETER Interbody Fusion Device approved for use with INFUSET Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSET Bone Graft. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
37
2301VЯЭг ИАМИН ОИА НТЈАЭН ЭО ТИЭМТЯАЧЭО FoodienteinimbA pund bus booq
Indications for Use
502/08/08/06/09/19 09/180/2020 יינו mələrin məmələrin sahəsində aid bitki növü. İstinadlar Səsinə aid bitki növü. İstinadlar Sənədlər Səs Azərbaycan Respublikasının Sənədlər Sənədlər Səs Azərbayca
sinə aid bir növü. İstinadlar Singli (1977) Sing (1977) Sing (1977) Sing (1977) September (1987) September (1987) September (1988) September (1988) September (1988 Unknown
Device Name
matsvis In Obligas Lateral Spinal System
Indications for Use (Describe)
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າຣາເຣນາໄລໄດ້ (100 ຊະອຸປີ) (ອvods ປີຣາປີ ຫຼັງມີຈຳໄປນັ້ນ ລາວປີ ອອກໄລນ໌ 18 ປີ 27 ທາງປີ ຄ.ສ. 2001 ປີ 2017 ປີ 2017 ປີ 2019 ປີ 2019 ປີ 2019 ປີ 2012 ປີ 2012 ປີ 2012 ປີ 2012 ປີ 201 อนุมัติ พาริอุปกิน อนุ, เปไธยอนุเม่ง ค.ศ. 1447) แต่เริ่ม ปัจจุบัน โรเรเริ่ม เวลาร์! เวลาไม ธ ที่ จรม หง้า จริเมชน์ ชอบ notismodul of issess as liew as first one might for and bevordate ages visodial messed lening lerein a əh 10 gülədəl əh ildən ə əniq rayonun ədə bərasın surəyə notisxil kinəməlduv qiyməsi ilə əsasən inzibati əsasən və başının əsasən və başının əsasən və başının əsasən və başın trountest avirsisten on to sithour xis bat and baseles are odw. அலக beniles as .CON thim becompain sinə isə nəqli məşğul və yazıl ədəd olan əsasən və qalan mərkəzi mərkəzi ərazi ərazi ərazi və və yaxında ədə .2ləvəl bəvlovni ədə tə zirədlərini və sisəsindən bəstəsinə olan əvasın osla own 10 and 18 date 1 in 1 in 1 in 1 a 1 an 2 2 me 2 menoquoo metry 2 lange least 1 supild 0 MTXOVIA and 11 am 19 11 19 11 19 bəzu nətin .ən və və və və və və və və və və tsiount ( { ;(sembert guibuloui) emner! ( ; ;seipus vider une your in the views your your your your your your นุนัพ ที่สิทธิ จักษรออรม่า 10 มหาวิท ปี เป้นพระราชอิต เท่ารถอย่างๆ เทพี่เรา 10 แลนด์อุปอง อน 3 นินที่แป ərində məlumatı və ya noyasılıları yarınqanın əti ni əsu və bərəndan və və sinə qanın əraz ənəd bir əsrlər ານອອກເຂົ້າ ເປີ ອອກສາການປະຊາກອນຮຽນ ການປະກວດນາມເຮັກໄທວັນທີ່ສະໜາມ ລາວປະຣາທິກາ ອປີ ຂອງປະເທດ ınlırısında (CI-I II) mövlərini ən əvvəl isə ən ən ildə bura şəxdənir ralınasın ətirəsindən əmələ çəkilməsindən ədə mələdir. Əhali vasitəsinin ədə əsirən müxtəli kiməməldur isə səs pərçələri ərazi vaxtar və və bur ətriq mətsinə kənd. ƏupildO MIXOVIY ədili .notifibroo sidir diya ətrafından və su 100 bəhsiləri toru ildən ən bir baxı əsasən və baxı əsasən və baxı əsərləri əsasən və ba MISSUAN . 1280100 supildo 10 lerests nego 10 avissvari villaminim 6 1861 strands 1 aviteredo -non to shund xis bat and but entrem Mittelsen ed blueds sincited were e lighed of touriste us a size and server and the bested in hodder umulos romand of pear at use mes mes mess mess many of man si first of the contral and one minere personal pur . sanimas vanoibaibriisting guibrages ənbild və xalq ədə əsas ətirəsdə ətir ucun mərkəzi və qadının vinanların və mənilər. Ən qalan məşğul və bir məşğulan mən ST-ST mort dəstəsinin (ALO) unistr 19 milli 1978 m əsrin 1991 əldən 1991 səsinə 1997 nəfər 2001 nəfər 2001 to sasis nishts . Issorggs supildo 10 lereist nedo 10 evizsvali vilkminim s siv beinskumi sesti ", membert Type of Use (Select one or ordod, as applicable)
ESPECIAL COM MUITO RECHEIO DE GANACHE
APROXIMADAMENTE 130 GRAMAS
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38
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A would a many and a mark and and on mach as a many and and
təqvi olunmuşdur. Bu minin bura nəqli bir nəzərində araşında mərkəzi və mənən mənən bir mən :of ,пәртиф гін) ഉпірирет тог гиоітердиг риірырыі ,поіраецца пойлатногиі гістур əd bulbulanı ,əsnoqsə nəq sınad etməyə ət bətəmirəs si noitəsiləsi ilə nəirəsinə sinfi tot əmir nəbrud ədə
səsinə aid bitki növü. İstinadlar Şamanın Qara Şəxsi Şamanın Şəxslərin Şamanın Şərqlər Şərqi Şərqi Şərqi Şərqi Şərqi Şərqi Şərqi Şərqi Şərqlər Şərqi Şərqlər vop.sq1d.ebj@jtkbSAA99 A (AAA) As A A (PRA) Star olice of Chief Information Ofice noitentsinimbA purC bus bood
าด แต่เวอร์เดอ ย
39
| 0479-844 (10E) ຂອງເປນອະ ອຸດທີ່ສຸລິໄປນາ ປີຣົມ
| на | ുറ | מילי (1888) 1888 מערב המקום המורח במקום המו | ||
|---|---|---|---|---|
| സ് സ്ഥിത ലേഖ | ||||
| səsinə aid bitki növü. İstinadlar Şərqində Şərqindən Şəxsi və bir və bir və bir və mənin sənət və mənin sənət və mənist | əsindən bir bəyən ərəb ətir bürcü burada çərənin ərazisindən ilk bir müxtəli və müxtəli və mü | |||
| :of ,nebud sint puisuber 107 suoitseppus puibuloni ,noitsellos noitsmuonii sidi 10 | ||||
| מור (AA99) וכא חסולוגע מעולם על המחירות המוזיקה במקום המוזיקה במקום המוזיקה במקום המוזיקה במקום המוזיקה במקום המו | ||||
| uoitentsinimbA purq bus bood | ||||
| າ ອວ | ||||
| vop.squr.ebj@jtkkSAA9 | ||||
| əri Şuban Şəhər Şamanın Qaran Qaran Qaran Qara Qaran Qara Qaran Qara Qaran Qara Qaran Qara Qaran Qara Qaran Qara Qaran Qara Qaran Qara Qaran Qara | əsində ilə sənədlər və bərənin əsasən bir nərədlər sini roy əmir nəbədə və bir və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və və v | |||
| . WOJB SSBROA JIAMS ATATS ASS SHT OT MAOJ GETTY MAON ANDY GREAST ON OG | ||||
| .5881 to 13A noitoubeA xiowreds9 ອກ to ຂ້າມອາເມຣາເນຊອາ ອາໄປທຸລະ ແມ່ນອະຣາເປັນ | ||||
| .0303311 11 30A9 ЭТАЯАЯЭг А ИО ЭUИIТИОЭ | ||||
| (2 นิย์ที่มีความ 2008 มี 2008 ครั้ง ครั้ง ครั้ง ครั้ง (2) | (0 นิธีรัตน์ (108 สิวิ 12 นิษย์) อรม แอมป์ตุ่าวิชา (X | (əldəsilddə sə 'iltod 10 əuo isələsi əsrl to ədvi | ||
| (นักมี พ.ศ. 2555 ตัว เพื่อเวรา เอาร์) แต่ประเทศ (เรนทางประเทศ | ||||
| əsinə ən "81 nəfər rəhərin sistemin viliyəsindən viliyəsi təsvir ədəd və və və və və və və və və və və və və və və və və və və və və v | ||||
| ın bəxri yolla minarlı E thim bəsn ədəd bir mətsis larıda "Turisis və ən təsvirən ənalə başın məni | ||||
| əubildə bax ısının əbaləsində əsərli .əsləsənda əvizevni ilkaninin əsasən və yelindən | ||||
| themised and to supers of the every bas suitem villetelesse of blueds simitser of tourist of tourist of tourist of tourist of tourist of tourist of tourist of tourist of tour | ||||
| əsində səs bəriləsi sinfindən ildə bir sənəl zimai sunun (QQQ) əsəsin əsib əsir əsir əsrin əsasən tirin | ||||
| sunar ui ətrinası worman ənəd tirinci ilə bir baxılman 10/2an filmləri 2017-ci ildə 2001-cü ildə 2001-cü ildə 2001-cü illərdən | ||||
| soversion MTT Sphings System | ||||
| lshinameldus lawoiiibbe 'sweiss bebiyord əyi 10 əncə 10 5 mart 15 sm ol səsoods müisiisiya ədə 11 . smələsindən əldərir. 1 | ||||
| lə rədmur yurdulm bəsu zi əsirlər bəzi ədən ədə TSUM ətslq 1970-cü ildən əldə 1972-ci ildə ilə və ildə ilə və və ildə ilə və i | ||||
| əd varı sinfi ilə bir və qaran (norinxil və ya mərkəd və məlibbə çənin bir və qalından və min | ||||
| ən ildə və mənilər bir sistemin məsasən ləvəliyyət qalan mənad niyanın qil əsr və bərbələri və mətra | ||||
| lanida "Trajersvog ədə yillarının siyasiyada bura yoluna baxıb ədə ən çoxdur və nərənələrən mən | ||||
| ال نواحياتينين ويندو ويوروووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووو | ||||
| ال 2022202 | ||||
| ການປະກວດນາງງາມ ເຖິ່າຈາກບ່າວວານ 10 ອວນາອ່າ ອາດໄລ-busite 6 ຂຣ ນ້ອຂາ ອປ ບຸຣາມ ກາຣປະປຸດ ໄທພັດໃ "Fugiers ຈາກ | ||||
| latingsa bus sisolloss əvirində divi bəsongsib sinərirə ai noisul of tomips an sa zinətindən və bəsn vədən | ||||
| əmin əsinə q | ||||
| (umoux yı) vədmun (xi) (xəstə | ||||
| woled themately ARA Pea | ||||
| ESOSIOE/190 : etc@ noiteriax. | superior suoitesibu | |||
| uoitentsinimbA pund bus bood | ||||
| יינוני 1900 ₪ 800 ₪ 800 ₪ 800-01-01 | 2301V932 ИАМИН ОНА НТЈАЭН ЗО ТИЗМТЯАЧА |
40
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | K192502
Page 20 of 21
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number ( if known ) | |
| Device Name | T2 Stratosphere(TM) Expandable Corpectomy System (Cervical and Thoracolumbar) |
| Indications for Use (Describe) | |
| The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients. | |
| When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. | |
| When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Corpectomy centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. | |
| When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate used at the surgeon's discretion. | |
| Type of Use ( Select one or both, as applicable ) | |
| | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
41
. WOJER SSAREDA JIAMS FRATS ASS SHT OT MAON GETTY AMOS ANDY GNAS TON OG*
təqvi olunmuşdur. Bu miştirir bura sonra sənədlər məşğul və mələnməsi və mənisələr mən :of ,nebrud sint puisuber 107 suoitseppys pribuloni ,noitsellos noitemnonni sinfi 10 əd biribiləri ,əsnoqsən rəq sunun olan mitəsinin əsasən və insinə aid növlətinin əmir nəbrud əsr
vob.syy.ebj@gyaatsAAA səsinə saxların bura qılların inzinan əsasən və qarşı və qarşı və qalındırılmışdır. Bu və mənist יישוב (גורר (גרמני) וכית חסוים ומרים בין מיני (ג'ונג 1997) והיית מו າອວ Food anninistration
io uoillean e 'o' buoqsar o' bainbal in nosted e brie 'iosuods 10 'yem your en your en your your your your your your your your your your your your your your you ". ເອປັນນາ ຊື່ທີ ນິ້ນາ ບຸກຄອນນວ ຣ ເຊຍຊາວລາວ ເດຍນ້ອຍການປູກເທ