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Curiteva Porous PEEK Cervical Interbody System
The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended to be used with supplemental fixation. The Curiteva Porous PEEK Cervical Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Curiteva Porous PEEK Lumbar Interbody System
The Curiteva Porous PEEK Lumbar lnterbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.

Curiteva Porous PEEK Laminoplasty System
The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Curiteva Porous PEEK Standalone ALIF System
The Curiteva Porous PEEK Standalone ALIF devices are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

Curiteva Porous PEEK ALIF System (Without Integrated Fixation)
The Curiteva Porous PEEK ALIF devices are intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

The previously cleared devices consist of a variety of interbody implants and spacers to provide support in the cervical, thoracic, lumbar, and/or lumbosacral regions of the spine. The system implants feature a proprietary nanomaterial surface treatment. This nanoscale surface texture is engineered to produce a uniform nanocrystalline hydroxyapatite layer approximately 10 – 20 nm thick, with individual crystals averaging 91.5 nm in length, and an average width of 10 nm. The surface has demonstrated the ability to reduce contact angle (i.e., increase hydrophilicity) as compared to uncoated and micro-sized HA coated control surfaces and demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

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The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended to be used with supplemental fixation. The Curiteva Porous PEEK Cervical Interbody Fusion System is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally box-shaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

The purpose of this submission is to update the indications for use and to introduce new sizes to the Curiteva Porous PEEK Cervical Interbody Fusion System.

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The Sync Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Sync VBR Fusion System is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The Sync Cervical Interbody Fusion System is an anterior interbody fusion device for use in the cervical spine (C2-T1). The Sync VBR Fusion System is a vertebral body replacement device for use in the cervical and thoracic spine. Interbody and VBR Fusion components are available in a variety of heights and footprints to suit the individual pathology and anatomy of the patient. The device components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or PEEK conforming to ASTM F2026. The PEEK interbody fusion device components have tantalum marker pins manufactured from tantalum per ASTM F560 for radiographic visualization.

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The aprevo® cervical ACDF interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The devices are to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The aprevo® cervical ACDF interbody system must be used with supplemental fixation (e.g., cervical plate or cervical posterior fixation).

The aprevo® cervical ACDF-X interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The devices are to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. When used with the screws that accompany the device, the aprevo® cervical ACDF-X interbody system is intended for use as a standalone system. Deformity procedures to correct coronal angulation or use of a hyperlordotic device (>20° lordosis) must include supplemental fixation (e.g., cervical plate or cervical posterior fixation).

The aprevo® cervical interbody system, which is comprised of the aprevo® cervical ACDF interbody system and the aprevo® cervical ACDF-X interbody system configurations, is designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® cervical interbody system interbody devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile, and the screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody devices, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single patient use.

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MSFX Mikron Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level(C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and implanted with auto graft/autologous bone graft. They are to be used with supplemental fixation.

MSFX Mikron Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/ autologous bone graft to facilitate fusion for each spinal region.

The MSFX Mikron Peek Cages are intervertebral body fusion devices to be implanted into appropriate cervical and lumbar spine. MSFX Mikron Peek Cages are composed of:

• MSFX Mikron Cervical Peek Cages
• MSFX Mikron Lumbar Peek Cages

MSFX Mikron Cervical Peek cages are designed to maintain the height of the intervertebral space. It is used in surgical procedures where two or more vertebrae are connected or fused together to achieve fusion in spinal disorders. It supports bone fusion and is available in different shapes and sizes. The cage body is made from PEEK (ASTM F2026), and the pin, marker and screws are produced from Ti6Al4V ELI (ASTM F136). They are to be used with supplemental fixation, placed via anterior approach and implanted with autograft/autologous bone graft.

MSFX Mikron Lumbar Peek cages are designed to maintain the height of the intervertebral space. It is used in surgical procedures where two or more vertebrae are connected or fused together to achieve fusion in spinal disorders. It supports bone fusion and is available in different shapes and sizes. The cage body is made from PEEK (ASTM F2026), and the pin, marker and expansion mechanism are produced from Ti6Al4V ELI (ASTM F136). The devices are designed to be used with supplemental fixation and autograft/ autologous bone graft to facilitate fusion for each spinal region.

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The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SPINELINC Cervical Spacer Body and Anterior Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with three SpineLinc screws per assembly.

The SpineLinc Anterior Cervical Implant system consists of a cervical interbody fusion device, cervical plate, screws, and a locking clip, which may be implanted in various configurations to accommodate patient anatomy. The SpineLinc Anterior Cervical implant devices are offered manufactured from titanium alloy per ASTM F136 or ASTM F3001. Instrumentation is provided with the SpineLinc Anterior Cervical Implant system to facilitate implantation. Instruments are manufactured from medical grade stainless steel per ASTM F899. All subject implants and instruments are provided sterile via gamma irradiation and are provided as single use kits.

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The Dakota LP Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Dakota LP Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The Dakota LP Anterior Cervical Interbody Fusion System includes cervical interbody fusion spacers to provide mechanical support of the cervical spine until fusion of the treated level occurs. The Dakota LP Anterior Cervical Interbody Fusion System implants are offered in a variety of sizes to accommodate patient anatomical needs and are manufactured from Ti-6Al-4V ELI per ASTM F3001 (cages) and Magnolia PEEK per ASTM F2026 with Tantalum per ASTM F560 (cages) with or without commercially pure titanium coating per ASTM F67.

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EFFORTMED CERVICAL PEEK CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. CERVICAL PEEK CAGES facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autograft/autologous bone graft. Patients should have received at least six (6) months of prior non-operative treatment. EFFORTMED CERVICAL PEEK CAGES are to be used with supplemental fixation.

The EFFORTMED LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.

The EFFORTMED ORIZABA CERVICAL CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The EFFORTMED COTOPAXI LUMBAR CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The ORIZABA and COTOPAXI CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

ORIZABA and COTOPAXI CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

The EffortMed spinal interbody cage system includes cervical intervertebral body fusion (IBFD), transforaminal lumbar interbody fusion (TLIF), and posterior lateral interbody fusion (PLIF) devices. The cervical cage models are the EffortMed Pacaya Cervical PEEK Cage and Masaya Augmented Cervical PEEK cage. The lumbar cage models are the EffortMed TLIF PEEK Cage, Effortmed TLIF PEEK Cage 4° Angled, Effortmed PLIF PEEK Cage, EffortMed PLIF PEEK Cage 5° Angled, and EffortMed Expandable PLIF PEEK Cage. The system was designed to restore height and lordotic angle in the spine. The main role of the cages is to help maintain the cleared disc space stable and intact, until a healthy bony fusion occurs between the adjoining vertebrae. To help achieve this, the inner chamber of the cage body is filled with bone graft before implantation.

The system also includes cervical and corpectomy cages (identified as used in cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to, tumors, fractures, and infections. The corpectomy cage models are the EffortMed Orizaba Cervical Corpectomy cage and EffortMed Cotopaxi Lumbar Corpectomy cage.

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BEE HA cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The subject BEE HA cage is an anterior cervical interbody fusion device. BEE HA cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form.

BEE HA cage is intended for single use only and is provided sterile, using gamma irradiation.

The purpose of this traditional 510k is to expand the size range offerings for the previously cleared BEE HA.

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