(132 days)
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 fication. 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 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.
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 maybe 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-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 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."
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.
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.
The ANATOMIC PEEK 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. 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 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. 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 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 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 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 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 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.
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 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.
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-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.
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.
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.
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.
This document describes Medtronic Sofamor Danek's intervertebral body fusion spinal systems and a Special 510(k) submission to update the indications for use. The core of this request is to support the use of demineralized allograft bone with bone marrow aspirate in these devices.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Original Indications) | Reported Device Performance (New Indication) |
|---|---|
| The interbody fusion devices (various Medtronic systems like ANATOMIC PEEK, Capstone, Clydesdale, Cornerstone, Crescent, Divergence, Elevate, Perimeter, Pivox, Sovereign) are indicated for interbody fusion procedures. | The new indication for use expands the acceptable bone graft material to include demineralized allograft bone with bone marrow aspirate in addition to autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft. This applies across all the listed interbody fusion systems. |
| These devices are intended to be used with: | |
| * Autogenous bone graft | The study provided "published clinical outcomes to support the use of demineralized allograft bone with bone marrow aspirate" as an adjunct to fusion for these devices. |
| * Allograft bone graft comprised of cancellous and/or corticocancellous bone graft | The efficacy and safety of the devices with this new graft material are considered "substantially equivalent" to predicate devices (ARTIC-L™ 3D and ARTIC-XL™ 3D Ti Spinal System with TiONIC™ Technology K190959 and Endoskeleton TA Interbody Fusion Device, etc. K192018) which already support the use of demineralized allograft bone combined with bone marrow aspirate. No new performance testing (mechanical, biocompatibility) was required for this particular submission. This suggests the change is primarily an expansion of an existing material indication based on established clinical data for similar devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for a "test set" in the context of device performance testing. It states: "The subject application provides published clinical outcomes to support the use of demineralized allograft bone with bone marrow aspirate." This implies a review of existing literature rather than a new, dedicated clinical study conducted by Medtronic for this 510(k) submission.
- Sample Size (Test Set): Not explicitly stated as a separate "test set" was not created for this submission. The support comes from "published clinical outcomes."
- Data Provenance: The data provenance is described as "published clinical outcomes." No specific country of origin or whether the data was retrospective or prospective is mentioned in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As noted above, there was no separate "test set" created by Medtronic for this submission. The clinical evidence relies on published literature regarding the use of demineralized allograft bone with bone marrow aspirate. The expertise for establishing the ground truth would therefore reside within the authors and peer-review process of those published studies.
4. Adjudication Method for the Test Set
Not applicable, as there was no new, specific test set created by Medtronic for this 510(k) where expert adjudication would be required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use." The change is based on a review of published clinical outcomes for the bone graft material, not a comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a medical implant (intervertebral body fusion system) and not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. Type of Ground Truth Used
The ground truth for concluding the safety and effectiveness of the expanded indication (use of demineralized allograft bone with bone marrow aspirate) is based on published clinical outcomes. This implies that peer-reviewed literature and clinical evidence from human patients using this type of bone graft material formed the basis for the regulatory decision.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The submission focuses on an expanded indication for an existing, cleared medical device based on clinical evidence for a specific bone graft material.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device that requires a training set.
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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 USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738 | |
| Contact(s) | Emmarie HaltemanRegulatory Affairs SpecialistDirect Telephone – 901-399-2216 | |
| DatePrepared | August 6, 2021 | |
| TradeNames | ANATOMIC PEEK™ Cervical Fusion SystemANATOMIC PEEK™ PTC Cervical Fusion Spinal SystemCapstone™ Spinal SystemCapstone Control™ Spinal SystemCapstone Control PTC™ Spinal SystemCapstone PTC™ Spinal SystemClydesdale™ Spinal SystemClydesdale PTC™ Spinal SystemCornerstone™ PSR Cervical Fusion SystemCrescent™ Spinal SystemCrescent™ Spinal System TitaniumDivergence-L™ Anterior/Oblique Lumbar Fusion SystemDivergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only)Elevate™ Spinal SystemPerimeter Interbody Fusion DevicePivox™ Oblique Lateral Spinal SystemSovereign™ Spinal SystemT2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) | |
| Classification Names | Intervertebral Fusion Device with Bone Graft, LumbarIntervertebral Fusion Device with Integrated Fixation, LumbarSpinal Vertebral Body Replacement DeviceIntervertebral Fusion Device with Bone Graft, CervicalIntervertebral Fusion Device with Integrated Fixation, Cervical | |
| RegulatoryClass | Class II | |
| RegulationNumber | 888.3080; 888.3060 | |
| RegulationName | Intervertebral Body Fusion Device; Spinal Intervertebral Body Fixation Orthosis | |
| DeviceProductClassification Code | MAX; OVD; MQP; PLR; ODP; OVE | |
| PredicateDevices | Primary Predicate:ARTIC-L™ 3D and ARTIC-XL™ 3D Ti Spinal System withTiONIC™ 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 SystemSovereign™ Spinal SystemT2 Stratosphere™ Expandable Corpectomy System (Cervicaland 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 | ||
| Descriptionof Device | ||
| ANATOMICPEEK™ CervicalFusion System | The ANATOMIC PEEK Cervical Fusion System consists of cages ofvarious widths and heights which can be inserted betweentwo cervicalvertebral bodies to give support and correction during cervical interbodyfusion surgeries. The hollow geometry of the implants allows them to bepacked with autogenous bone and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone graft, and/or demineralizedallograft bone with bone marrow aspirate. The ANATOMIC PEEKdevices must be used with supplemental fixation. | |
| ANATOMICPEEK™ PTCCervical FusionSpinal System | The ANATOMIC PEEK™ PTC Cervical Fusion System consists of cagesof various widths and heights which can be inserted betweentwo cervicalvertebral bodies to give support and correction during cervical interbodyfusion surgeries. The hollow geometry of the implants allows them to bepacked with autogenous bone and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone graft, and/or demineralizedallograft bone with bone marrow aspirate. The ANATOMIC PEEK™PTC devices must be used with supplemental fixation. | |
| Capstone™ SpinalSystem | The CAPSTONE™ Spinal System consists of PEEK cages, titanium alloycages, and titanium cages of various widths and heights, which canbeinserted between two lumbar or lumbosacral vertebral bodies to givesupport and correction during lumbar interbody fusion surgeries. Thehollow geometry of the implants allows them to be packed withautogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograftbone with bone marrow aspirate. | |
| Capstone Control™Spinal System | The CAPSTONE CONTROL™ Spinal System consists of PEEK cages ofvarious widths and heights, which can be inserted between two lumbar orlumbosacral vertebral bodies to give support and correction during lumbarinterbody fusion surgeries. The hollow geometry of the implants allowsthem to be packed with autogenous bone and/or allograft bone graftcomprised of cancellous and/or corticocancellous bone graft, and/ordemineralized allograft bone with bone marrow aspirate. See the MDTCatalog or price list for further information about warranties andlimitations of liability. | |
| Capstone ControlPTCTM SpinalSystem | The CAPSTONE CONTROL PTC™ Spinal System consists ofcommercially pure titanium (CP Ti) coated PEEK cages ofvarious widthsand heights, which can be inserted between two lumbar or lumbosacralvertebral bodies to give support and correction during lumbar interbodyfusion surgeries. The hollow geometry of the implants allows them to bepacked autogenous bone and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone graft, and/or demineralizedallograft bone with bone marrow aspirate. | |
| Capstone PTCTMSpinal System | The CAPSTONE PTCTM Spinal System consists of commercially puretitanium (CP Ti) coated PEEK cages of various widths and heights, whichcan be inserted between two lumbar or lumbosacral vertebral bodies to givesupport and correction during lumbar interbody fusion surgeries. Thehollow geometry of the implants allows them to be packed withautogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograftbone with bone marrow aspirate. | |
| Clydesdale™ SpinalSystem | The CLYDESDALE® Spinal System consists of PEEK cages of variouswidths and heights, which include Tantalum markers. These devices can beinserted between two lumbar or lumbosacral vertebral bodies to givesupport and correction during lumbar interbody fusion surgeries. Thehollow geometry of the implants allows them to be packed withautogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograftbone with bone marrow aspirate. | |
| Clydesdale™ SpinalSystem (w/Infuse) | The CLYDESDALE® Spinal System consists of PEEK cages of variouswidths and heights, which include Tantalum markers. These devices can beinserted between two lumbar or lumbosacral vertebral bodies to givesupport and correction during lumbar interbody fusion surgeries. Thehollow geometry of the implants allows them to be packed autogenousbone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone withbone marrow aspirate, or INFUSE® Bone Graft as designated below. | |
| Clydesdale PTCTMSpinal System | The CLYDESDALE PTCTM Spinal System consists of commercially puretitanium (CP Ti) coated PEEK cages of various widths and heights, whichinclude tantalum markers. These devices can be inserted between twolumbar or lumbosacral vertebral bodies to give support and correctionduring lumbar interbody fusion surgeries. The hollow geometry of theimplants allows them to be packed with autogenous bone and/or allograftbone graft comprised of cancellous and/or corticocancellous bonegraft, and/or demineralized allograft bone with bone marrow aspirate. | |
| Cornerstone™ PSRCervical FusionSystem | The CORNERSTONE® PSR Cervical Fusion System consists of cages ofvarious widths and heights, which can be inserted between two cervicalvertebral bodies to give support and correction during cervical interbodyfusion surgeries. The hollow geometry of the implants allows them to bepacked with autogenous bone and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone graft, and/or demineralizedallograft bone with bone marrow aspirate in cervical fusion procedures.The CORNERSTONE® PSR device is to be used with supplementalinstrumentation and is to be implanted via an open, anterior approach. Seethe MDT Catalog or price list for further information about warranties andlimitations of liability. | |
| Crescent™ SpinalSystem | The CRESCENT® Spinal System consists of PEEK cages of variouswidths and heights which can be inserted between two lumbar orlumbosacral vertebral bodies to give support and correction during lumbarinterbody fusion surgeries. The hollow geometry of the implants allowsthem to be packed with autogenous bone and/or allograft bone graftcomprised of cancellous and/or corticocancellous bone graft, and/ordemineralized allograft bone with bone marrow aspirate. The implantsmay be implanted via a posterior, transforaminal or lateral approach andthe procedure may be open or minimally invasive. See the MDT Catalog or | |
| price list for further information about warranties and limitations ofliability. | ||
| CrescentTM SpinalSystem Titanium | The CRESCENT® Spinal System Titanium consists of implant grade titaniumalloy (Ti-6Al-4V) cages of various widths and heights which can be insertedbetween two lumbar or lumbosacral vertebral bodies to give support andcorrection during lumbar interbody fusion surgeries. The hollow geometry ofthe implants allows them to be packed with autogenous bone and/or allograftbone graft comprised of cancellous and/or corticocancellous bone graft,and/or demineralized allograft bone with bone marrow aspirate. Theimplants may be implanted via a transforaminal or lateral approach and theprocedure may be open or minimally invasive. | |
| Divergence-LTMAnterior/ObliqueLumbar FusionSystem | The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System consists ofplates, bone screws, and interbody cages. The DIVERGENCE-LTMAnterior/Oblique Lumbar Fusion System plates and bone screws are available ina broad range of size offerings intended for anterior screw fixation andstabilization during the normal healing process following surgical correction ofdisorders of the spine. Fixation is provided by bone screws inserted into thevertebral body of the lumbar spine using an anterior or oblique approach. TheDIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System plate and bonescrews are made from titanium alloy and are provided sterile. Additionally, theDIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody cagesmay be used as supplemental fixation when used in conjunction with posteriorfixation devices to treat deformity conditions in the thoracic and lumbar spine.The hollow geometry of the implants allows them to be packed with autogenousbone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate or INFUSETM Bone Graft (as designated below). The cagesare manufactured from medical grade polyetheretherketone (PEEK) and titaniumalloy with tantalum markers and are provided sterile. | |
| Divergence™Anterior CervicalFusion System(For Stand-AloneInterbody DeviceOnly) | The DIVERGENCET™ Anterior Cervical Fusion System is an intervertebralbody fusion device with internal screw fixation. The system is comprised of aninterbody cage and bone screws. These implants are for single use only. TheDIVERGENCET™ anterior cervical cages are provided in 0 and 6 degrees oflordosis, 5-12mm heights, 15-20mm widths and 12- 16mm depths. This device isintended to be radiolucent, and the interior space of the product is to be usedwith autogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograft bonewith bone marrow aspirate . The DIVERGENCET™ stand-alone cervicalinterbody device is manufactured from medical grade polyetheretherketone(PEEK) and contains radiopaque markers made from medical grade titaniumalloy. The PEEK interbody cage also comes preassembled with a titanium alloy,built- in rotary locking mechanism. The bone screws used with this device areprovided in self-drilling and self-tapping options and are manufactured frommedical grade titanium alloy. The bone screws are provided in 3.5mm and4.0mm diameters and 9-17mm lengths. The PEEK material used conforms toASTM F2026 and the titanium alloy material used conformsto ASTM F136. Toachieve best results, do not use any of the DIVERGENCETM™ Anterior CervicalFusion System implant components with components from any other system ormanufacturer unless specifically allowed to do so in this or another Medtronicdocument. As with all orthopaedic and neurosurgical implants, none of theDIVERGENCETM Anterior Cervical Fusion System components should ever bereused under any circumstances. | |
| Elevate™ SpinalSystem | The ELEVATET™ Spinal System is an expandable PEEK, Tantalum, andTitanium alloy interbody device consisting of various lengths and startingheights, which can be inserted between two lumbar or lumbosacral vertebralbodies to give support and correction during lumbar interbody fusion surgeries.The ELEVATET™ Spinal System expands for adjustable lordosis and height tomatch patient anatomy. The hollow geometry of the implants allows them to bepacked with autogenous bone and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone graft, and/or demineralizedallograft bone with bone marrow aspirate . The implants may be implanted viaa posterior or transforaminal approach and the procedure may be open orminimally invasive. The ELEVATET™ Spinal System can be implantedunilaterally and bilaterally. The ELEVATET™ Spinal System is intended to beinserted with ELEVATET™ Spinal System reusable instruments. ELEVATETMSpinal System implants are for single use only. | |
| Perimeter InterbodyFusion Device | The PERIMETER® Interbody Fusion Device consists of cages of variouswidths and heights which can be inserted between two lumbar or lumbosacralvertebral bodies to give support and correction during lumbar interbody fusionsurgeries. The hollow geometry of the implants allows them to be packed withautogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograft bonewith bone marrow aspirate . The PERIMETER® Interbody Device is to beused with supplemental fixation instrumentation. The device is offered inTitanium Alloy (Titanium- 6Aluminum-4Vanadium ELI) or PEEK(Polyetheretherketone). This interbody device is offered in sterile or non-sterileforms. Refer to the package label for specific implant sterility information. ThePERIMETER® Interbody Fusion Device is offered in a variety of sizes rangingfrom 8mm to 20mm in height, 15mm to 28mm in length, and between 19mmand 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™ ObliqueLateral SpinalSystem | The PIVOX™ Oblique Lateral Spinal System consists of interbody cages,plates, and bone screws. The PIVOX™ Oblique Lateral Spinal Systeminterbody cages are available in various widths, heights, and lordosis insertedbetween two lumbar vertebral bodies to give support and correction duringlumbar interbody fusion surgeries. The hollow geometry of the implants allowsthem to be packed with autogenous bone and/or allograft bone graftcomprised of cancellous and/or corticocancellous bone graft, and/ordemineralized 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. ThePIVOX™ Oblique Lateral Spinal System plates and bone screws are availablein a broad range of sizes intended for anterior column screw fixation andstabilization during the normal healing process following surgical correction ofdisorders of the spine. Fixation is provided by bone screws inserted into thevertebral body of the lumbar spine using an anterior, lateral, or obliqueapproach. The PIVOX™ Oblique Lateral Spinal System plate and bone screwsare made from titanium alloy and are provided sterile. | |
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| Sovereign™ SpinalSystem | The SOVEREIGN™ Spinal System is an intervertebral body fusion devicewith internal screw fixation. The screws protrude through the interbody portionof the device and stabilize the vertebral body while preventing expulsion of theimplant. The implant is lens-shaped with 3 holes for placement of titaniumscrews using an anterior or oblique approach. The SOVEREIGN™ SpinalSystem contains both a fixed and a variable angle screw option. The fixedangle screw option provides an interference fit with the polyetheretherketone(PEEK) interbody implant. The variable angle screw option provides a slightclearance between the PEEK interbody implant and the screw which allows fora small amount of variable screw angulation. This system is intended to beradiolucent and the interior space of the product is to be used with autogenousbone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone withbone marrow aspirate. The accompanying cover plate is designed to resistscrew backout and must be used when the variable angle screws are implanted.The SOVEREIGN™ Spinal System interbody device is manufactured fromPEEK (polyetheretherketone) and contains tantalum radiopaque markers. Thescrews used with this device are manufactured from titanium alloy. | |
| T2 Stratosphere™ExpandableCorpectomy System(Cervical andThoracolumbar) | The T2 Stratosphere™ Expandable Corpectomy System is an adjustablevertebral body replacement device and features a self- adjusting end cap whichprovides continuous angulation between 0-8° in any direction to accommodatethe patient's anatomical requirements. T2 Stratosphere™ ExpandableCorpectomy System devices for use in the thoracolumbar and cervical spineare restricted to the 13mm diameter centerpieces. The T2 Stratosphere™Expandable Corpectomy System is made of titanium alloy and is providedsterile and non-sterile. This device is inserted between two vertebral bodies inthe thoracolumbar or cervical spine and is expanded to aid in the surgicalcorrection and stabilization of the spine. The centerpieces are available inmultiple heights. The system also features modular end caps which areavailable in various angles and diameters and are only for use in thethoracolumbar spine. The device is not intended to be used as a stand-aloneimplant. | |
| No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particularpurpose or use are specifically excluded. | ||
| Never use titanium or titanium alloy implants with stainless steel in the same construct. | ||
| Indicationsfor Use: | ANATOMICPEEKTM CervicalFusion System | The ANATOMIC PEEK Cervical Fusion System is indicated for cervical interbodyfusion procedures in skeletally mature patients with cervical disc disease at one levelfrom the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractableradiculopathy and/or myelopathy with herniated disc and/or osteophyte formation onposterior vertebral endplates producing symptomatic nerve root and/or spinal cordcompression confirmed by radiographic studies. This device is to be used in patientswho have had six weeks of non-operative treatment. The ANATOMIC PEEK deviceis to be used with supplemental fixation. The ANATOMIC PEEK Cervical FusionSystem is also required to be used with autogenous bone and/or allograft bonegraft comprised of cancellous and/or corticocancellous bone graft, and/ordemineralized allograft bone with bone marrow aspirate and is to be implantedvia an open anterior approach. |
| ANATOMICPEEKTM PTCCervical FusionSpinal System | The ANATOMIC PEEK PTC Cervical Fusion System is indicated for use in skeletallymature patients with degenerative disc disease (DDD) of the cervical spine withaccompanying radicular symptoms at atone disc level or two contiguous levels. DDDis defined as discogenic pain with degeneration of the disc confirmed by patent historyand radiographic studies. The ANATOMIC PEEK PTC Cervical Fusion System isused to facilitate intervertebral body fusion in the cervical spine and is placed via ananterior approach from the C2-C3 disc space to the C7-T1 disc space usingautogenous bone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate. The ANATOMIC PEEK PTC Cervical Fusion System is to be usedwith supplemental fication. Patients should have at least six weeks of non-operativetreatment prior to treatment with an intervertebral cage. | |
| CapstoneTM SpinalSystem | The CAPSTONE® Spinal System is intended to be used in spinal fusion proceduresfor patients diagnosed with Degenerative Disc Disease (DDD) at one or twocontiguous levels from L2 to S1. DDD patients may also have up to Grade 1Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined asdiscogenic back pain with degeneration of the disc confirmed by history andradiographic studies. When used for these indications, the CAPSTONE® SpinalSystem is intended for use with supplemental fixation systems cleared for use in thelumbar spine.Additionally, the CAPSTONE® Spinal System can be used to provide anteriorcolumn support in patients diagnosed with degenerative scoliosis as an adjunct topedicle screw fixation. These patients should be skeletally mature and have had sixmonths of nonoperative treatment. The CAPSTONE® Spinal System is intended to beused with autogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograft bone withbone marrow aspirate when the subject device is used as an adjunct to fusion. Theseimplants may be implanted via an open or a minimally invasive posterior approach.Alternatively, these implants may also be implanted via an anterior and/ortransforaminal approach. | |
| Capstone Control™Spinal System | The Capstone Control™ Spinal System is intended to be used in spinal fusionprocedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2contiguous levels from L2 to S1. DDD patients may also have up to Grade 1spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenicback pain with degeneration of the disc confirmed by history and radiographic studies.When used for these indications, the Capstone Control™ Spinal System is intendedfor use with supplemental fixation systems cleared for use in the lumbar spine.Additionally, the Capstone Control™ Spinal System can be used to provide anteriorcolumn support in patients diagnosed with degenerative scoliosis as an adjunct topedicle screw fixation. These patients should be skeletally mature and have had 6months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised ofcancellous 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 ControlPTC™ SpinalSystem | 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 PTCTMSpinal System | The CAPSTONE PTC™ Spinal System is indicated for interbody fusion in patientswith Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. TheseDDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at theinvolved levels. DDD isdefined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies. These patients should be skeletallymature and have had six months of non-operative treatment. Additionally, theCAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinaldeformity as a supplement to pedicle screw fixation in patients diagnosed withdegenerative scoliosis. These implants may be implanted via an open or a minimallyinvasive posterior approach. Alternatively, these implants may also be implanted viaan anterior and/or transforaminal approach. These implants are to be used withautogenous bone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate. These devices are intended to be used with supplemental fixationinstrumentation, which has been cleared by the Food and Drug Administration (FDA)for use in the lumbar spine. | |
| Clydesdale™ SpinalSystem | The CLYDESDALE® Spinal System is designed to be used with autogenous boneand/or allograft bone graft comprised of cancellous and/or corticocancellousbone graft, and/or demineralized allograft bone with bone marrow aspirate tofacilitate interbody fusion and is intended for use with supplemental fixation systemscleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used forpatients diagnosed with degenerative disc disease (DDD) at one or two contiguouslevels from L2 to S1. These DDD patients may also have up to Grade 1Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenicback 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-operativetreatment. These implants may be implanted via a minimally invasive lateralapproach. | |
| Clydesdale™ SpinalSystem (w/ Infuse) | The CLYDESDALE® Spinal System is intended to be used in interbody fusionprocedures for patients diagnosed with Degenerative Disc Disease (DDD) at one ortwo contiguous levels from L2 to S1. DDD patients may also have up to Grade 1Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined asdiscogenic back pain with degeneration of the disc confirmed by history andradiographic studies. When used for these indications, the CLYDESDALE® SpinalSystem is intended for use with supplemental fixation systems cleared for use in thelumbar spine.Certain sizes of the CLYDESDALE® Spinal System may be used with INFUSE®Bone Graft in single-level Oblique Lateral Interbody Fusion (OLIF) procedures fromL2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling forthe INFUSE® Bone Graft/Medtronic Interbody Fusion Device for information on thespecific sizes of the CLYDESDALE® Spinal System approved for use withINFUSE® Bone Graft, as well as specific information regarding contraindications,warnings, and precautions associated with INFUSE® Bone Graft. INFUSE® BoneGraft is not indicated for use in a direct lateral interbody fusion (DLIF) surgicalapproach.Additionally, the CLYDESDALE® Spinal System can be used to provide anteriorcolumn support in patients diagnosed with degenerative scoliosis as an adjunct topedicle screw fixation. INFUSE® Bone Graft is not indicated for use in patients withthis condition.These patients should be skeletally mature and have had six months of nonoperativetreatment. The CLYDESDALE® Spinal System is intended | |
| to be used with autogenous bone and/or allograft bone graft comprised ofcancellous and/or corticocancellous bone graft, and/or demineralized allograftbone with bone marrow aspirate when the subject device is used as an adjunct tofusion. These implants may be implanted via a minimally invasive lateral approach. | ||
| Clydesdale PTCTMSpinal System | The CLYDESDALE PTC™ Spinal System is designed to be used with autogenousbone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate to facilitate interbody fusion and is intended for use withsupplemental fixation systems cleared for use in the lumbar spine. TheCLYDESDALE PTC™ Spinal System is used for patients diagnosed withDegenerative 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 atthe involved levels. DDD is defined as discogenic back pain with degeneration of thedisc confirmed by history and radiographic studies. These patients should be skeletallymature and have had six months of non-operative treatment. These implants may beimplanted via a minimally invasive lateral approach. | |
| Cornerstone™ PSRCervical FusionSystem | The CORNERSTONE® PSR device is indicated for cervical interbody fusionprocedures in skeletally mature patients with cervical disc disease at one level fromthe C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractableradiculopathy and/or myelopathy with herniated disc and/or osteophyte formation onposterior vertebral endplates producing symptomatic nerve root and/or spinal cordcompression confirmed by radiographic studies. This device is to be used in patientswho have had six weeks of non-operative treatment. The CORNERSTONE® PSRdevice is to be used with supplemental fixation. The CORNERSTONE® PSR deviceis also required to be used with autogenous bone and/or allograft bone graftcomprised of cancellous and/or corticocancellous bone graft, and/ordemineralized allograft bone with bone marrow aspirate and is to be implanted viaan open, anterior approach. | |
| Crescent™ SpinalSystem | The CRESCENT™ Spinal System is indicated for interbody fusion in patients withDegenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDDpatients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevels. DDD is defined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies. These patients should be skeletallymature and have had six months of non-operative treatment. These implants are to beused with autogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograft bone withbone marrow aspirate . These devices are intended to be used with supplementalfixation instrumentation which has been cleared by the FDA for use in the lumbarspine. | |
| Crescent™ SpinalSystem 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-LTMAnterior/ObliqueLumbar FusionSystem | 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 InterbodyFusion Device (w/Infuse) | The PERIMETER® Interbody Fusion Device is indicated for interbody fusion withautogenous bone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate in patients with degenerative disc disease (DDD) at one or twocontiguous levels from L2 to S1. These DDD patients may also have up to Grade 1Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined asdiscogenic back pain with degeneration of the disc confirmed by history andradiographic studies. These patients should be skeletally mature and have had sixmonths of non-operative treatment. These implants may be implanted via a variety ofopen or minimally invasive approaches. These approaches include anterior, lateral,and oblique. These devices are intended to be used with supplemental fixationinstrumentation, which has been cleared for use in the lumbar spine.Certain sizes of the PEEK PERIMETER® Interbody Fusion Device may also be usedwith INFUSE® Bone Graft for patients diagnosed with DDD, as defined above. Thedevice 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 levelusing an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. ThePEEK PERIMETER® Interbody Fusion Device should be used with supplementalfixation systems cleared for use in the lumbar spine. Consult the labeling for the | |
| Pivox™ ObliqueLateral SpinalSystem | The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be usedwith autogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograft bone withbone marrow aspirate to facilitate interbody fusion and is intended for use withsupplemental fixation systems cleared for use in the lumbar spine. The PIVOX™Oblique Lateral Spinal System interbody cage is used for patients diagnosed withdegenerative 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 theinvolved levels. DDD is defined as discogenic back pain with degeneration of thedisc confirmed by history and radiographic studies.Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provideanterior column support in patients diagnosed with degenerative scoliosis as anadjunct to pedicle screw fixation. These patients should be skeletally mature andhave had six months of non- operative treatment.These implants may be implanted via a minimally invasive or open lateral or obliqueapproach. Certain sizes of the PIVOX™ Oblique Lateral Spinal System InterbodyCage may also be used with INFUSE™ Bone Graft for patients diagnosed withDDD, 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 ObliqueLateral Interbody Fusion (OLIF) approach from L2- L5 and is intended for use withsupplemental fixation systems cleared for use in the lumbar spine. Consult thelabeling for the INFUSE™ Bone Graft/ Medtronic Interbody Fusion Device forinformation on the specific sizes of the PIVOX™ Oblique Lateral Spinal SystemInterbody Cage approved for use with INFUSE™ Bone Graft, as well as specificinformation regarding contraindications, warnings, and precautions associated withINFUSE™ 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 provideanterior column support in patients diagnosed with degenerative scoliosis as anadjunct to pedicle screw fixation. These patients should be skeletally mature andhave had six months of non-operative treatment. These implants may be implantedvia a minimally invasive or open lateral or oblique approach. INFUSE™ Bone Graftis not indicated for use in patients with this condition. The PIVOX™ Oblique LateralSpinal System plate and bone screw components are indicated as a supplementalfixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) ofthe vascular structures, and oblique or lateral above the bifurcation (L1-L5) of thevascular structures. The indications and contraindications of spinal instrumentationsystems should be understood by the surgeon. The plate and bone screw componentsare indicated for use in the temporary stabilization of the anterior lumbar spineduring the development of spinal fusions in patients with: 1) DDD defined by backpain of discogenic origin with degeneration of the disc confirmed by patient historyand radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformitydefined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failedprevious fusions. When used together, the PIVOX™ Oblique Lateral Spinal Systemcomponents can be used to treat patients with DDD at one or two contiguous levelsfrom L2 to S1 (except as defined for use with INFUSE™ Bone Graft above). TheseDDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at theinvolved levels. | ||
| Sovereign™ SpinalSystem | The SOVEREIGN™ Spinal System is indicated for use with autogenous bonegraft and/or allograft bone graft comprised on cancellous and/orcorticocancellous bone graft, and/or demineralized allograft bone with bonemarrow aspirate in patients with degenerative disc disease (DDD) at one or twocontiguous levels from L2 to S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies. Additionally,the SOVEREIGN™ Spinal System is indicated for use in patients diagnosed withmultilevel degenerative scoliosis and sagittal deformity conditions as an adjunct tofusion. 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 patientsdiagnosed with multilevel degenerative scoliosis and sagittal deformity conditions,additional supplemental fixation (e.g. posterior fixation) must be used. Theseimplants may be implanted via a variety of open or minimally invasive approaches.These approaches include anterior and oblique. The SOVEREIGN™ interbodysystem may be used as a stand-alone device or in conjunction with supplementalfixation. When used as a stand-alone device, the SOVEREIGN™ interbody device isintended 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 anynumber of variable angle screws. If the physician chooses to use less than 3 or noneof the provided screws, additional supplemental fixation in the lumbar spine must beused to augment stability. Implants with lordosis angles greater than 18° are intendedto be used with supplemental fixation (e.g. facet screws or posterior fixation). | |
| T2 Stratosphere™ExpandableCorpectomy System(Cervical andThoracolumbar) | The T2 Stratosphere™ Expandable Corpectomy System is a vertebral bodyreplacement device intended for use in the thoracic and lumbar spine (T1-L5) andcervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System isintended for use in skeletally mature patients. When used in the cervical spine, the T2Stratosphere™ Expandable Corpectomy System is used to replace a collapsed,damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), orosteomyelitis, or for reconstruction following corpectomy performed to achievedecompression of the spinal cord and neural tissues in cervical degenerativedisorders. | |
| When used in the cervical spine, the T2 Stratosphere™ Expandable CorpectomySystem may not be used with optional modular end caps. When used in the cervicalspine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy Systemis intended to be used with supplemental fixation for use in the cervical spine. Whenused at more than two levels, supplemental fixation should include posterior fixationcleared for use in the cervical spine. When used in the thoracic and lumbar spine, theT2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed,damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2Stratosphere™ Expandable Corpectomy centerpiece may be used with or withoutoptional modular end caps which accommodate individual anatomic requirements.The device is to be used with supplemental fixation cleared for use in the thoracic andlumbar spine.When used in the cervical spine, the T2 Stratosphere™ Expandable CorpectomySystem is intended for use with autogenous bone and/or allograft bone graftcomprised of cancellous and/or corticocancellous bone graft, and/ordemineralized allograft bone with bone marrow aspirate as an adjunct to fusion.When used in the thoracic and lumbar spine, the T2 Stratosphere™ ExpandableCorpectomy System is intended for use with autogenous bone and/or allograftbone graft comprised of cancellous and/or corticocancellous bone graft, and/ordemineralized allograft bone with bone marrow aspirate as an adjunct to fusion.The T2 Stratosphere™ Expandable Corpectomy System is also intended to restorethe integrity of the spinal column even in the absence of fusion for a limited time inpatients with advanced stage tumors involving the cervical and/or thoracolumbarspine in whom life expectancy is of insufficient duration to permit achievement offusion, with autogenous bone and/or allograft bone graft comprised of cancellousand/or corticocancellous bone graft, and/or demineralized allograft bone withbone marrow aspirate used at the surgeon's discretion. | ||
| Comparison ofTechnologicalCharacteristics with thePredicateDevices | 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 predicatedevices. The predicate and subject devices are intended for stabilization use and to promote bone fusion duringthe normal healing process following surgical correction of disorders of the spine. The subject devices wereoriginally cleared for use with autogenous bone and/or allograft bone graft comprised of cancellous and/orcorticocancellous bone graft. The subject application provides published clinical outcomes to support theuse of demineralized allograft bone with bone marrow aspirate. | |
| PerformanceData | No performance testing was required or performed, as this modification for this Special 510(k) relates only tothe indications for use. | |
| BiocompatibilityNo new implants or instruments were included in this submission. | ||
| Mechanical TestingNo new mechanical testing was performed or required to support this application. | ||
| Design ValidationNo new Design Validation testing was required as this submission does not include any new or modifiedinstruments or implants. A minor change was included in the surgical technique, but this only involves theinclusion of demineralized allograft bone mixed with bone marrow aspirate and does not impact implant orinstrument design. | ||
| Clinical OutcomesClinical outcomes on the usage of demineralized allograft bone combined with bone marrow aspirate wereprovided to support this application. | ||
| Conclusion | Based upon the supporting documentation provided in the pre-market notification, the subject devices are safeand effective as the primary predicates ARTIC-L™ 3D Ti Spinal System and the ARTIC- XL™ 3D Ti SpinalSystem found in K190959 and Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TASHyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT InterbodyFusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device,Endoskeleton TL Interbody Fusion Device – K192018, when demineralized allograft bone combined with bonemarrow aspirate is used. |
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| 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:
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"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 |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
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| 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:
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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) | |
|---|---|---|---|---|
| to uoillee e 'ot puodser of periupes tou si nosted e publication in tourism vonelle andinformation unders it bildisting a currently of the number | ||||
| səsinə səslərin bura diləsini təsvirində qalınmışdır. Bu məmmədə q | əsindən bir bəhri və qədən sinfi bulbuna sinə mürəsində məsk müsaməsində mənəd birinci ilə sənəqsən rəq suran və bətənirəs si notirəsmənin to noixəllər sinfi növəmin ən:of to. WOJER 223900A JIAMS 47ATS ASA 3HT OT MAO3 AUDY GN32 TON OG*. See to is a noitoubes your to stremeriuper of vino seilqqs noitoes singរ០ ចៈ នប្បៈ នេះ វា ជា ជា វិញ ជួន អ្នកon of the fine frief from only of Chicalthe starte And Action and (ARA) StarFor and inimises purchisisticolor | |||
| SEEDE | ||||
| (0 heqdus 108 Я금2 12) өгப 19,000 годагы салтын төмө [ | Type of Use (Steer one or out, as applicable)(0 กิโยตุนาร 108 ภาว 12 ริการ 12 กิโรค) อรม แม่เปที่มีของคน 2 | |||
| ında və bir bəyəldən ədəd vəm sinəldən əsəd. Aləsindən A. dəstəqa əvvərənələr vilanının və nəqənın siy bəlusları ədə çəm sinə qalında ot təminə aid əsər si əsirəsi təsvir nəhv əlavəsindən ən qwith the bestile with a mories and such as a commend of parties and or bergolesxis barl əvəd bura əmləm yllarında sənərində əsərlər. mərkəzi və əsər ələnməsi və səsinə əvvəl əsasənroluna ənədlər də qalında çəkili sinfinə mərkəzi varilə məninə mənin əsasən əsrin əsasən və silən məna market sureits and the minent rolleting of bess and mes mestyle tenige MIENOTSA Self, yfleriotibbeəniqç radınıl ədə ilə bərələ smətəyə noğrazlı ilə əsu 101 bəbəsini si mətsiya larıq? MƏNƏTƏ MƏəth suoitasibui əsəlli 101 bəzu nədli . səiblir əiqisid və vioisid vd bəmriliyossaib ətti 10 noitristio, qu əvarl ozla van zinəitəd QQQ .IS ot 27 mort eləvəl suouzində ən ən çı (QQQ) əsasiQ əsiQ əsiddirə nisq yosd əinəgəsin as bəriləb si QQQ ləvəl bəvlovni ətt tə sisədir.ilovforma isəsinə ilə baxındırım bəsonların və səmbəsov qolsul kurds ut bəsu əd ot bəbirəini si mərasın kimidə müharində əhli | of the successioning approses.Indications for Use (Describe) | |||
| Capitone™ Spinsteməmində əsinə q | ||||
| ប្រហូរ ប្រក្រ(1900) (Number (19) Kumoviy | ||||
| See PRA Staterent below0202108190 Doster: 0 noiteniqxヨ | ndications for Use | |||
| Form Approved: ONB BMB. 0810-0120 | 2301V932 ИАМИН ОИА НТЈАЭН ЗО ТИЭМТЯАЧЭОuoitersinimbA pung bus bood | |||
| 17252502I 2 to E 9869 | ||||
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| 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
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Office of Chief Information Officer
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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}------------------------------------------------
| K192502Page 6 of 21 | |
|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration 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}------------------------------------------------
| K192502Page 7 of 21 | DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration |
|---|---|
| Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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) | |
|---|---|
| </span> 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}------------------------------------------------
| K192502Page 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 SERVICESFood and Drug Administration | Page 10 of 21 | |
|---|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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 bayrağı0202/08/08/08 09:18:00 noiteriax3 | |
|---|---|---|
| UMouxuՈ510(k) Number (if known | ||
| Crescent™ Spinal System TitaniumDəvicəs 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 ລາວເກົ່າວຂອworld in and thergolls bezilsranimes rolbus .flarg and suollesarsoning 10/bus suollesurs to berinquosthere and thersofils to but should think beau of on and of one studios and to situs andxis bad əvan buran vilktələk əd birində əsərlər. Səibur əldərənibər bura vəsini və bəmilyan əsasən vəlo 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 qəssəsib əsir əsrlərənə qalındırılır. 10 bərəsini 10 bəhsiləri ilə münatin mətrilə kənd. 1977-cü ildə 1972-cü ildə 197I 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 OGYSEEL 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 müə 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 toəri gübuləni ,əsnoqsən ədən et bərənirə si noitəməlir. To noitəlilər sinfi növələr əldə ən mənilə ən mənist məbul ədə | ||
| vop.syy.repl@gggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggggroitersisinimbA purq bus boodses 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 the้างอิง | ||
| (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 Paन 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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{34}------------------------------------------------
| K192502Page 14 of 21 | |
|---|---|
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood 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) 443-6740EF |
|---|---|---|
| ---------------------- | ------------- | ---------------------------------------------- |
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}------------------------------------------------
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Indications for Use
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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
(0 treading 108 Я 77 1 2 1169) ອະປີ noitqinoser9 (X (ວັນນາຣຸປຸດົມ ນິຍົມ ໂດຍ ກິຈິງ ອະປະເທດວ-ອຸປັນ - ເອທດ
1903311 11 30A9 3TA9A932 A NO 3UNITHO3
{38}------------------------------------------------
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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
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| 0479-844 (10E) ຂອງເປນອະ ອຸດທີ່ສຸລິໄປນາ ປີຣົມна | ു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 10מור (AA99) וכא חסולוגע מעולם על המחירות המוזיקה במקום המוזיקה במקום המוזיקה במקום המוזיקה במקום המוזיקה במקום המוuoitentsinimbA purq bus boodາ ອວvop.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 (เรนทางประเทศəsinə 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 vın bəxri yolla minarlı E thim bəsn ədəd bir mətsis larıda "Turisis və ən təsvirən ənalə başın məniəubildə bax ısının əbaləsində əsərli .əsləsənda əvizevni ilkaninin əsasən və yelindənthemised 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 tourəsində səs bəriləsi sinfindən ildə bir sənəl zimai sunun (QQQ) əsəsin əsib əsir əsir əsrin əsasən tirinsunar ui ətrinası worman ənəd tirinci ilə bir baxılman 10/2an filmləri 2017-ci ildə 2001-cü ildə 2001-cü ildə 2001-cü illərdənsoversion MTT Sphings Systemlshinameldus lawoiiibbe 'sweiss bebiyord əyi 10 əncə 10 5 mart 15 sm ol səsoods müisiisiya ədə 11 . smələsindən əldərir. 1lə 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 iəd varı sinfi ilə bir və qaran (norinxil və ya mərkəd və məlibbə çənin bir və qalından və minən ildə və mənilər bir sistemin məsasən ləvəliyyət qalan mənad niyanın qil əsr və bərbələri və mətralanida "Trajersvog ədə yillarının siyasiyada bura yoluna baxıb ədə ən çoxdur və nərənələrən mənال نواحياتينين ويندو ويورووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووال 2022202ການປະກວດນາງງາມ ເຖິ່າຈາກບ່າວວານ 10 ອວນາອ່າ ອາດໄລ-busite 6 ຂຣ ນ້ອຂາ ອປ ບຸຣາມ ກາຣປະປຸດ ໄທພັດໃ "Fugiers ຈາກlatingsa bus sisolloss əvirində divi bəsongsib sinərirə ai noisul of tomips an sa zinətindən və bəsn vədənəmin əsinə q | ||||
| (umoux yı) vədmun (xi) (xəstə | ||||
| woled themately ARA PeaESOSIOE/190 : etc@ noiteriax. | superior suoitesibuuoitentsinimbA pund bus bood | |||
| יינוני 1900 ₪ 800 ₪ 800 ₪ 800-01-01 | 2301V932 ИАМИН ОНА НТЈАЭН ЗО ТИЗМТЯАЧА |
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | K192502Page 20 of 21Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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. |
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. 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
§ 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.