(267 days)
The Stryker Spine Aero™ -AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™ - AL Lumbar Cage System is to be implanted via an anterior approach.
The Aero™ - AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that has been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.
The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
The Stryker Spine Aero™ - LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™ -LL Lumbar Cage System is to be implanted via a lateral approach.
The Aero™ -LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Tl, for the treatment of cervical disc disease (defined as neck pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The Ascential IBD PEEK. Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.
The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy 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 AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by the AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be vice is used with any number of screws.
The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® TL PEEK Spacers are to be implanted via posterior approach.
The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectorny cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be sketally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be sketally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥10°) are required to be used with an atterior cervical plate as the form of supplemental fixation.
When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).
The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine Monterey™ AL Interbody System - Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in 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 history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.
The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation),
The Stryker Spine Monterey™ AL Interbody System – Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in 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 history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.
The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.
The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (TI-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The Trianium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD pairents may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® PL Cage is to be implanted via a posterior approach.
The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium TL Cage is to be implanted via a posterior approach.
The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autografic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Trianium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (TI-LS) to replace a collapsed, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to turnor of trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFTM include, but are not limited to Stryker Spine plate or rod system, Spiral Radius 90D, and Trio). The use of bone graft with VLIFTTM is optional.
VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (TI-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.
The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is 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.
The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
The subject devices consist of a variety of intervertebral body fusion devices and spinal vertebral body replacement devices designed to provide support across implanted levels of the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved and have been previously cleared by FDA. The purpose of this submission is to establish an MR Conditional labeling claim for these implants.
This document is a 510(k) Summary for a range of spinal implants. The purpose of this submission is to establish an MR Conditional labeling claim for these implants. The submission does not detail specific acceptance criteria or performance metrics beyond stating that MR Compatibility testing was performed and met acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or reported device performance for the various spinal implants. It states generally:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| MR Compatibility per ASTM F2503-13 | The test results demonstrate that the subject devices' performance met the prescribed acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set (number of devices tested).
- Data Provenance: The data appears to be from laboratory testing ("MR Compatibility testing per ASTM F2503-13 was performed"). There is no mention of country of origin for data or whether it was retrospective or prospective. Given the nature of MRI compatibility testing for medical implants, it would typically be prospective laboratory testing on a selection of devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for MRI compatibility testing of physical implants is based on validated test methods (ASTM F2503-13) and physical measurements of artifacts, heating, and forces, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images by multiple readers to establish a "ground truth" for diagnosis or assessment. MRI compatibility testing involves physical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states this submission is to establish an MR Conditional labeling claim for physical implants. It is not a study comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This submission is for physical medical devices (spinal implants) and their MRI compatibility, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for this type of submission is established through physical measurements and adherence to recognized standards (ASTM F2503-13) for evaluating MRI safety and compatibility of medical implants.
8. Sample Size for the Training Set
This information is not applicable. There is no AI or algorithm that requires a training set mentioned in this submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for an AI/algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure. The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well.
February 14, 2023
Stryker Spine Ms. Renée Norby Staff Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K221490
Trade/Device Name: Tritanium® C Anterior Cervical Cage, Tritanium® PL Cage, Tritanium® TL Curved Posterior Lumbar Cage, Tritanium® X PL Expandable Posterior Lumbar Cage, Tritanium® X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT" Vertebral Body Replacement System. VLIFT -s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero™-AL Lumbar Cage System, Aero" -LL Lumbar Cage System, Aero®-C Cervical Cage System, AVS® Aria PEEK Spacer, AVS® Anchor-C Cervical Cage System, AVS® Anchor-L Spacer, AVS® TL PEEK Spacer, AVS® PL PEEK Spacer, AVS® AL PEEK Spacer, AVS® UniLIF PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® AS PEEK Spacer, Monterey " AL Interbody System, Aleutian IBF System, Capri Corpectomy Cage System, Cascadia Interbody System, Chesapeake Stabilization System, Mojave Expandable Interbody System, Sahara Stabilization System, Santorini Corpectomy Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, OVD, MOP, PLR Dated: January 13, 2023
Received: January 13, 2023
Dear Ms. Norby:
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
{1}------------------------------------------------
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.
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 (QS) 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, 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
{2}------------------------------------------------
510(k) Number (if known) K221490
Device Name Aero™-AL Lumbar Cage System
Indications for Use (Describe)
The Stryker Spine Aero™ -AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™ - AL Lumbar Cage System is to be implanted via an anterior approach.
The Aero™ - AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that has been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| 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
{3}------------------------------------------------
510(k) Number (if known)
K221490
Device Name Aero®-C Cervical Cage System
Indications for Use (Describe)
The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.
| 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
{4}------------------------------------------------
510(k) Number (if known) K221490
Device Name Aero™-LL Lumbar Cage System
Indications for Use (Describe)
The Stryker Spine Aero™ - LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™ -LL Lumbar Cage System is to be implanted via a lateral approach.
The Aero™ -LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.
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
{5}------------------------------------------------
510(k) Number (if known) K221490
Device Name Aleutian IBF System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Tl, for the treatment of cervical disc disease (defined as neck pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
| 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
{6}------------------------------------------------
510(k) Number (if known) K221490
Device Name Ascential IBD PEEKc Spacer
Indications for Use (Describe)
The Ascential IBD PEEK. Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
| 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
{7}------------------------------------------------
510(k) Number (if known)
Device Name AVS® AL PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.
The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral 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
{8}------------------------------------------------
510(k) Number (if known)
Device Name AVS® Anchor-C Cervical Cage System
Indications for Use (Describe)
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy 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 AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
{9}------------------------------------------------
510(k) Number (if known) K221490
Device Name AVS® Anchor-L Spacer
Indications for Use (Describe)
The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by the AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be vice is used with any number of screws.
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."
{10}------------------------------------------------
510(k) Number (if known) K221490
Device Name AVS® Aria PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral 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
{11}------------------------------------------------
510(k) Number (if known) K221490
Device Name AVS® AS PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Type of Use (Select one or both, as applicable)X 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
{12}------------------------------------------------
510(k) Number (if known)
K221490
Device Name AVS® Navigator PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.
The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral 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
{13}------------------------------------------------
510(k) Number (if known)
Device Name AVS® PL PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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."
{14}------------------------------------------------
510(k) Number (if known) K221490
Device Name AVS® TL PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® TL PEEK Spacers are to be implanted via posterior approach.
The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
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
{15}------------------------------------------------
510(k) Number (if known) K221490
Device Name AVS® UniLIF PEEK Spacer
Indications for Use (Describe)
The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.
The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
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."
{16}------------------------------------------------
510(k) Number (if known)
Device Name Capri Corpectomy Cage System
Indications for Use (Describe)
CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectorny cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
| 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."
{17}------------------------------------------------
510(k) Number (if known) K221490
Device Name Cascadia Interbody System
Indications for Use (Describe)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be sketally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be sketally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥10°) are required to be used with an atterior cervical plate as the form of supplemental fixation.
| 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
{18}------------------------------------------------
510(k) Number (if known)
Device Name Chesapeake Stabilization System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).
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
{19}------------------------------------------------
510(k) Number (if known) K221490
Device Name Mojave Expandable Interbody System
Indications for Use (Describe)
The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
{20}------------------------------------------------
510(k) Number (if known)
K221490
Device Name Monterey AL Interbody System
Indications for Use (Describe)
Monterey™ AL Interbody System - Stand-Alone
The Stryker Spine Monterey™ AL Interbody System - Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in 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 history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.
The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation),
Monterey™ AL Interbody System - Spacer
The Stryker Spine Monterey™ AL Interbody System – Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in 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 history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.
The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
{21}------------------------------------------------
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
{22}------------------------------------------------
510(k) Number (if known) K221490
Device Name Sahara Stabilization System
Indications for Use (Describe)
The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
| Type of Use (Select one or both, as applicable) |
|---|
| X 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
{23}------------------------------------------------
510(k) Number (if known)
Device Name Santorini Corpectomy Cage System
Indications for Use (Describe)
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (TI-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and K2M Spinal Plate Systems.
When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
{24}------------------------------------------------
510(k) Number (if known) K221490
Device Name Tritanium® C Anterior Cervical Cage
Indications for Use (Describe)
The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The Trianium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| n |
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
{25}------------------------------------------------
510(k) Number (if known)
Device Name Tritanium® PL Cage
Indications for Use (Describe)
The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD pairents may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® PL Cage is to be implanted via a posterior approach.
The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral 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
{26}------------------------------------------------
510(k) Number (if known) K221490
Device Name
Tritanium® TL Curved Posterior Lumbar Cage
Indications for Use (Describe)
The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium TL Cage is to be implanted via a posterior approach.
The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral 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
{27}------------------------------------------------
510(k) Number (if known) K221490
Device Name
Tritanium® X PL Expandable Posterior Lumbar Cage
Indications for Use (Describe)
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autografic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Trianium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.
| 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) | ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ▢ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ❌ 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
{28}------------------------------------------------
510(k) Number (if known) K221490
Device Name
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Indications for Use (Describe)
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autografic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Trianium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.
| Type of Use ( Select one or both, as applicable ) |
|---|
| X 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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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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510(k) Number (if known)
Device Name
Stryker Spine VLIFT™ Vertebral Body Replacement System
Indications for Use (Describe)
Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (TI-LS) to replace a collapsed, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to turnor of trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFTM include, but are not limited to Stryker Spine plate or rod system, Spiral Radius 90D, and Trio). The use of bone graft with VLIFTTM is optional.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
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510(k) Number (if known) K221490
Device Name
VLIFT®-s Vertebral Body Replacement System
Indications for Use (Describe)
VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (TI-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.
The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is 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.
The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
| Type of Use ( Select one or both, as applicable ) |
|---|
| X 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."
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Page 1 of 21
Traditional 510(k)
MRI Compatibility – IBD and Corpectomy Systems
| 510(k) Summary | |
|---|---|
| Submitter: | Stryker Spine600 Hope Pkwy SELeesburg, VA 20175 |
| Contact Person : | Name: Renee NorbyPhone: 201-725-4954Email: renee.norby@stryker.com |
| Date Prepared: | 19-May-2022 |
| Trade Names: | 1. Tritanium® C Anterior Cervical Cage2. Tritanium® PL Cage3. Tritanium® TL Curved Posterior Lumbar Cage4. Tritanium® X PL Expandable Posterior Lumbar Cage5. Tritanium® X TL Expandable Curved Posterior Lumbar Cage6. Stryker Spine VLIFT™ Vertebral Body Replacement System7. VLIFT®-s Vertebral Body Replacement System8. Ascential IBD PEEKc Spacer9. Aero™-AL Lumbar Cage System10. Aero™-LL Lumbar Cage System11. Aero®-C Cervical Cage System12. AVS® Aria PEEK Spacer13. AVS® Anchor-C Cervical Cage System14. AVS® Anchor-L Spacer15. AVS® TL PEEK Spacer/AVS® TL PEEK Spacer Sterile16. AVS® PL PEEK Spacer17. AVS® AL/AVS® AL Sterile PEEK Spacer18. AVS® UniLIF PEEK Spacer19. AVS® Navigator PEEK Spacer20. AVS® AS PEEK Spacer21. Monterey™ AL Interbody System22. Aleutian IBF System23. Capri Corpectomy Cage System24. Cascadia Interbody System25. Chesapeake Stabilization System26. Mojave Expandable Interbody System27. Sahara Stabilization System28. Santorini Corpectomy Cage System |
| Common Name: | 1. Tritanium® CIntervertebral body fusion device2. Tritanium® PLIntervertebral body fusion device3. Tritanium® TLIntervertebral body fusion device |
| 510(k) Summary | |
| 4. | Tritanium® X PLIntervertebral body fusion device |
| 5. | Tritanium® X TLIntervertebral body fusion device |
| 6. | VLIFT™Spinal Vertebral Body Replacement System |
| 7. | VLIFT®-sSpinal Vertebral Body Replacement Device |
| 8. | Ascential IBD PEEKc SpacerCervical Interbody Device |
| 9. | Aero™-ALIntervertebral fusion device with integrated fixation, lumbar |
| 10. | Aero™-LLIntervertebral fusion device with integrated fixation, lumbar |
| 11. | Aero®-CIntervertebral fusion device with bone graft, cervical |
| 12. | AVS® AriaIntervertebral fusion device with bone graft, lumbar |
| 13. | AVS® Anchor-CIntervertebral fusion device with bone graft, cervical |
| 14. | AVS® Anchor-LIntervertebral fusion device with bone graft, lumbar |
| 15. | AVS® TL/AVS® TL SterileIntervertebral fusion device with bone graft, lumbar |
| 16. | AVS® PLIntervertebral fusion device with bone graft, lumbar |
| 17. | AVS® AL/AVS® AL SterileIntervertebral fusion device with bone graft, lumbar |
| 18. | AVS® UniLIFIntervertebral fusion device with bone graft, lumbar |
| 19. | AVS® NavIntervertebral fusion device with bone graft, lumbar |
| 20. | AVS® ASIntervertebral fusion device with bone graft, cervical |
| 21. | Monterey™ AL Interbody SystemIntervertebral body fusion device |
| 22. | Aleutian IBF SystemIntervertebral body fusion device |
| 23. | Capri Corpectomy Cage SystemVertebral body replacement device |
| 24. | Cascadia Interbody System |
| 510(k) Summary | |
| Intervertebral fusion device | |
| 25. Chesapeake Stabilization System | |
| Spinal fixation system | |
| 26. Mojave Expandable Interbody System | |
| Intervertebral fusion device with bone graft | |
| 27. Sahara Stabilization System | |
| Spinal fixation system | |
| 28. Santorini Corpectomy Cage System | |
| Vertebral body replacement device | |
| Proposed Class: | Class II |
| 1. Tritanium® CIntervertebral Body Fusion Device; 21 CFR §888.3080 | |
| 2. Tritanium® PLIntervertebral Body Fusion Device; 21 CFR §888.3080 | |
| 3. Tritanium® TLIntervertebral Body Fusion Device with Bone Graft, Lumbar; 21 CFR §888.3080 | |
| 4. Tritanium® X PLIntervertebral Body Fusion Device with Bone Graft, Lumbar; 21 CFR §888.3080 | |
| 5. Tritanium® X TLIntervertebral Body Fusion Device with Bone Graft, Lumbar; 21 CFR §888.3080 | |
| Classification Name: | 6. VLIFT™Spinal Intervertebral Body Fixation Orthosis; 21 CFR §888.3060 |
| 7. VLIFT®-sSpinal Intervertebral Body Fixation Orthosis; 21 CFR §888.3060 | |
| 8. Ascential IBD PEEKc SpacerIntervertebral Body Fixation Device; 21 CFR §888.3080 | |
| 9. Aero™-ALIntervertebral body fusion device; 21 CFR §888.3080 | |
| 10. Aero™-LLIntervertebral body fusion device; 21 CFR §888.3080 | |
| 11. Aero®-CIntervertebral body fusion device; 21 CFR §888.3080 | |
| 12. AVS® AriaIntervertebral body fusion device; 21 CFR §888.3080 | |
| 13. AVS® Anchor-CIntervertebral body fusion device; 21 CFR §888.3080 | |
| 14. AVS® Anchor-L | |
| 510(k) Summary | |
| 15. AVS® TL/AVS® TL Sterile | Intervertebral body fusion device; 21 CFR §888.3080 |
| 16. AVS® PL | Intervertebral body fusion device; 21 CFR §888.3080 |
| 17. AVS® AL/AVS® AL Sterile | Intervertebral body fusion device; 21 CFR §888.3080 |
| 18. AVS® UniLIF | Intervertebral body fusion device; 21 CFR §888.3080 |
| 19. AVS® Nav | Intervertebral body fusion device; 21 CFR §888.3080 |
| 20. AVS® AS | Intervertebral body fusion device; 21 CFR §888.3080 |
| 21. Monterey™ AL Interbody System | Intervertebral body fusion device; 21 CFR §888.3080 |
| 22. Aleutian IBF System | Intervertebral fusion device with bone graft, lumbar; 21 CFR §888.3080Intervertebral fusion device with bone graft, cervical; 21 CFR §888.3080Spinal vertebral body replacement device; 21 CFR §888.3060 |
| 23. Capri Corpectomy Cage System | Spinal intervertebral body fixation orthosis; 21 CFR §888.3060 |
| 24. Cascadia Interbody System | Intervertebral fusion device with bone graft, lumbar; 21 CFR §888.3080Intervertebral fusion device with integrated fixation, lumbar; 21 CFR §888.3080Intervertebral fusion device with bone graft, cervical; 21 CFR §888.3080 |
| 25. Chesapeake Stabilization System | Intervertebral body fusion device with integrated fixation; 21 CFR §888.3080 |
| 26. Mojave Expandable Interbody System | Intervertebral fusion device with bone graft, lumbar; 21 CFR §888.3080 |
| 27. Sahara Stabilization System | Intervertebral fusion device with integrated fixation, lumbar; 21 CFR §888.3080Intervertebral fusion device with bone graft, lumbar; 21 CFR §888.3080 |
| 28. Santorini Corpectomy Cage System | Spinal intervertebral body fixation orthosis; 21 CFR §888.3060 |
| Product Code: | 1. Tritanium® CODP |
| 2. Tritanium® PL | |
| 510(k) Summary | |
| MAX | |
| 3. Tritanium® TL | MAX |
| 4. Tritanium® X PL | MAX |
| 5. Tritanium® X TL | MAX |
| 6. VLIFT™ | MQP |
| 7. VLIFT®-s | PLR, MQP |
| 8. Ascential IBD PEEKc Spacer | ODP |
| 9. Aero™-AL | OVD |
| 10. Aero™-LL | OVD, MAX |
| 11. Aero®-C | ODP |
| 12. AVS® Aria | MAX |
| 13. AVS® Anchor-C | ODP |
| 14. AVS® Anchor-L | OVD, MAX |
| 15. AVS® TL/AVS® TL Sterile | MAX |
| 16. AVS® PL | MAX |
| 17. AVS® AL/AVS® AL Sterile | MAX |
| 18. AVS® UniLIF | MAX |
| 19. AVS® Nav | MAX |
| 20. AVS® AS | ODP |
| 21. Monterey™ AL Interbody System | OVD, MAX |
| 22. Aleutian IBF System | MAX, ODP, MQP |
| 510(k) Summary | |
| 23. Capri Corpectomy Cage SystemPLR, MQP | |
| 24. Cascadia Interbody SystemMAX, OVD, ODP | |
| 25. Chesapeake Stabilization SystemOVD, OVE | |
| 26. Mojave Expandable Interbody SystemMAX | |
| 27. Sahara Stabilization SystemOVD, MAX | |
| 28. Santorini Corpectomy Cage SystemPLR, MQP | |
| Predicate Devices: | Primary Predicate: Tritanium® C (K171496) |
| Additional Predicates: Tritanium® PL (K181014) | |
| Tritanium® TL (K173476) | |
| Tritanium® X PL (K183249) | |
| Tritanium® X TL (K183249) | |
| VLIFT™ (K060506) | |
| VLIFT®-s (K183071) | |
| Ascential IBD PEEKc Spacer (K161407) | |
| Aero™-AL (K143163) | |
| Aero™-LL (K142066) | |
| Aero®-C (K152532) | |
| AVS® Aria (K151726) | |
| AVS® Anchor C (K102606) | |
| AVS® Anchor L (K143163) | |
| AVS® TL/AVS® TL Sterile (K151726) | |
| AVS® PL (K151726) | |
| AVS® AL/AVS® AL Sterile (K151726) | |
| AVS® UniLIF (K151726) | |
| AVS® Nav (K151726) | |
| AVS® AS (K142251) | |
| Monterey™ AL Interbody System (K201585) | |
| Aleutian IBF System (K133614) | |
| Capri Corpectomy Cage System (K211320) | |
| Cascadia Interbody System (K172941) | |
| Chesapeake Stabilization System (K142487) | |
| Mojave Expandable Interbody System (K193203) | |
| Sahara Stabilization System (K190179) | |
| Santorini Corpectomy Cage System (K180665) | |
| 510(k) Summary | |
| Device Description: | The subject devices consist of a variety of intervertebral body fusion devicesand spinal vertebral body replacement devices designed to provide supportacross implanted levels of the cervical, thoracolumbar, and lumbosacral spineuntil fusion is achieved and have been previously cleared by FDA.The purpose of this submission is to establish an MR Conditional labelingclaim for these implants. |
| Intended Use: | Tritanium® CThe Tritanium® C Anterior Cervical Cage is indicated for use in cervicalinterbody fusion procedures in skeletally mature patients with degenerativedisc disease (DDD) at one level or two contiguous levels from the C2 to T1disc. |
| DDD is defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. These patients should beskeletally mature and have six weeks of non-operative therapy. | |
| The Tritanium® C Anterior Cervical Cage System is to be used withautogenous bone graft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft, and is to be implanted via an open,anterior approach. | |
| The Tritanium® C Anterior Cervical Cage System is intended to be used withsupplemental spinal fixation systems that have been cleared for use in thecervical spine. | |
| Tritanium® PLThe Stryker Spine Tritanium® PL Cage is an intervertebral body fusiondevice indicated for use with autograft and/or allogenic bone graft comprisedof cancellous and/or corticocancellous bone graft when used as an adjunct tofusion in patients with degenerative disc disease (DDD) at one level or twocontiguous levels from L2 to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade I spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy. | |
| Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion inpatients diagnosed with degenerative scoliosis. | |
| The Tritanium® PL Cage is to be implanted via a posterior approach. | |
| The Tritanium® PL Cage is intended to be used with supplemental spinalfixation systems that have been cleared for use in the lumbosacral spine. |
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K221490 Page 2 of 21
stryker
Traditional 510(k) MRI Compatibility – IBD and Corpectomy Systems
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K221490 Page 3 of 21
Traditional 510(k)
MRI Compatibility – IBD and Corpectomy Systems
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Page 5 of 21 Traditional 510(k) MRI Compatibility – IBD and Corpectomy Systems
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K221490 Page 6 of 21
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K221490 Page 7 of 21 Traditional 510(k) MRI Compatibility – IBD and Corpectomy Systems
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510(k) Summary Tritanium® TL The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Tritanium TL Cage is to be implanted via a posterior approach. The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Tritanium® X PL The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scollosis. The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. Tritanium® X TL The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X
TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral
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510(k) Summary
body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
VLIFT™
Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to tumor or trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT™ include, but are not limited to Stryker Spine plate or rod systems (Xia® Spinal System, Spiral Radius 90D, and Trio). The use of bone graft with VLIFT™ is optional.
VLIFT®-S
VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, 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 tissue in degenerative disorders.
The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in
{40}------------------------------------------------
510(k) Summary
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.
The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Ascential IBD PEEKc Spacer
The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.
Aero™ AL
The Stryker Spine Aero™ -AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™ - AL Lumbar Cage System is to be implanted via an anterior approach.
The Aero™ - AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.
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| 510(k) Summary | |
|---|---|
| Aero™ LLThe Stryker Spine Aero™ -LL is an intervertebral body fusion device indicatedfor use with autogenous bone graft in patients with degenerative disc disease(DDD) at one level or two contiguous levels from L2 to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade 1 spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy. | |
| The Aero™ -LL Lumbar Cage System is to be implanted via a lateral approach. | |
| The Aero™ -LL Lumbar Cage System is intended to be used with supplementalspinal fixation systems that have been cleared for use in the lumbosacralspine (e.g., posterior pedicle screw and rod systems). In addition, the devicemay be used with or without the included fixation anchors. | |
| Aero® CThe Stryker Spine AERO®-C Cervical Cage is indicated for use in cervicalinterbody fusion procedures in skeletally mature patients with degenerativedisc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc. | |
| DDD is defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. These patients should beskeletally mature and have six weeks of non-operative therapy. | |
| The AERO®-C Cervical Cage System is to be used with autogenous bone graftand/or allogenic bone graft comprised of cancellous and/or corticocancellousbone graft, and is to be implanted via an open, anterior approach. | |
| The AERO®-C Cervical Cage System is intended to be used with supplementalspinal fixation systems that have been cleared for use in the cervical spine. Inaddition, the device must be used with the included fixation anchors. | |
| AVS® AriaThe Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusiondevices indicated for use with autograft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft when thesubject device is used as an adjunct to fusion in patients with degenerativedisc disease (DDD) at one level or two contiguous levels from L2 to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade 1 spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy. | |
| Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct tofusion in patients diagnosed with degenerative scoliosis. | |
| 510(k) Summary | |
| The AVS® ARIA PEEK Spacers are intended to be used with supplementalfixation systems that have been cleared for use in the lumbosacral spine. | |
| AVS® Anchor CThe Stryker Spine AVS® Anchor-C Cervical Cage System is indicated foranterior cervical interbody fusion procedures in skeletally mature patientwith cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc | |
| 510(k) Summary | |
| subject device is used an adjunct to fusion in patients with degenerative discdisease (DDD) and one level or two contiguous levels from L2 to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade 1 spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy. | |
| Additionally, the AVS® TL PEEK Spacers can be used as an adjunct to fusionin patients diagnosed with degenerative scoliosis. | |
| The AVS® TL PEEK Spacers are to be implanted via posterior approach. | |
| The AVS® TL PEEK Spacers are intended to be used with supplementalfixation systems that have been cleared for use in the lumbosacral spine (i.e.,posterior pedicle screw and rod systems). | |
| AVS® PLThe Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers areintervertebral body fusion devices indicated for use with autograft and/orallogenic bone graft comprised of cancellous and/or corticocancellous bonegraft when the subject device is used as an adjunct to fusion in patients withdegenerative disc disease (DDD) at one level or two contiguous levels from L2to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. DDD patients may also haveup to Grade 1 spondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperative therapy. | |
| Additionally, the AVS® PL and AVS® UniLIF™ PEEK Spacers can be used asan adjunct to fusion in patients diagnosed with degenerative scoliosis. | |
| The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to beimplanted via posterior approach. | |
| The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended tobe used with supplemental spinal fixation systems that have been cleared foruse in the lumbosacral spine (i.e., posterior pedicle screw and rod systems). | |
| AVS® AL (AVS® AL Sterile)The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebralbody fusion devices indicated for use with autograft and/or allogenic bonegraft comprised of cancellous and/or corticocancellous bone graft when thesubject device is used an adjunct to fusion in patients with degenerative discdisease (DDD) and one level or two contiguous levels from L2 to S1. | |
| 510(k) Summary | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may alsohave up to Grade 1 spondylolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy. | |
| Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as anadjunct to fusion in patients diagnosed with degenerative scoliosis. | |
| The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterioror anterolateral approach. | |
| The AVS® AL and AVS® ALign PEEK Spacers are intended to be used withsupplemental fixation systems that have been cleared for use in thelumbosacral spine. | |
| AVS® UniLIFThe Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers areintervertebral body fusion devices indicated for use with autograft and/orallogenic bone graft comprised of cancellous and/or corticocancellous bonegraft when the subject device is used as an adjunct to fusion in patients withdegenerative disc disease (DDD) at one level or two contiguous levels from L2to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. DDD patients may also haveup to Grade 1 spondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperative therapy. | |
| Additionally, the AVS® PL and AVS® UniLIF™ PEEK Spacers can be used asan adjunct to fusion in patients diagnosed with degenerative scoliosis. | |
| The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to beimplanted via posterior approach. | |
| The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended tobe used with supplemental spinal fixation systems that have been cleared foruse in the lumbosacral spine (i.e., posterior pedicle screw and rod systems). | |
| AVS® NavThe Stryker Spine AVS® Navigator PEEK Spacers are intervertebral bodyfusion devices indicated for use with autograft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft when thesubject device is used as an adjunct to fusion in patients with degenerativedisc disease (DDD) at one level or two contiguous levels from L2 to S1. | |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. The DDD patients may also |
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lly mature patients sc 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 AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
AVS® Anchor L
The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a standalone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by the AVS® Anchor-L Fixation Screws and I.ocking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws.
AVS® TL (AVS® TL Sterile)
The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the
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510(k) Summary have up to Grade 1 spondvlolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The AVS® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach. The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine. AVS® AS The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach. The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Monterey™ AL Interbody System Monterey™ AL Interbody System - Stand-Alone The Stryker Spine Monterey™ AL Interbody System - Stand-Alone (AL Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in 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 history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis. The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.
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stryker
510(k) Summary
| 510(k) Summary |
|---|
| The Monterey™ AL Stand-Alone System may be used as a stand-alone deviceor in conjunction with supplemental fixation. When used as a stand-alonedevice, the Monterey™ AL Stand-Alone System must be used with the bonescrews provided and requires no additional supplemental fixation. IfMonterey™ AL Stand-Alone System is used with less than three or none of theprovided bone screws, then additional supplemental fixation that has beencleared by the FDA for use in the lumbosacral spine must be used to augmentstability. Hyperlordotic implants (>20° lordosis) are intended to be used withsupplemental fixation (e.g., posterior fixation). |
| Monterey™ AL Interbody System - SpacerThe Stryker Spine Monterey™ AL Interbody System – Spacer (AL Spacer) is anintervertebral body fusion device indicated for use with autograft and/orallogenic bone graft comprised of cancellous and/or corticocancellous bonegraft when used as an adjunct to fusion in patients with Degenerative DiscDisease (DDD) at one or two contiguous levels from L2-S1. |
| DDD is defined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. These DDD patients may alsohave up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).These patients should be skeletally mature and have six months of non-operative therapy. |
| Additionally, the Monterey™ AL Spacer System can be used as adjunct tofusion in patients diagnosed with degenerative scoliosis. |
| The Monterey™ AL Spacer System is intended to be implanted via an anteriorapproach. |
| The Monterey™ AL Spacer System is intended to be used with supplementalfixation systems that have been cleared by the FDA for use in the lumbosacralspine. |
| Aleutian IBF SystemWhen used as a cervical intervertebral body fusion device, the Aleutianimplants are indicated for spinal fusion procedures to be used withautogenous bone graft in skeletally mature patients. Cervical IBF implants areintended for use at one level in the cervical spine, from C2 to T1, for thetreatment of cervical disc disease (defined as neck pain of discogenic originwith degeneration of the disc confirmed by history and radiographic studies).The cervical device is intended to be used in patients who have had six weeksof non-operative treatment. |
| When used as a lumbar intervertebral body fusion device, the Aleutianimplants are indicated for spinal fusion procedures to be used withautogenous bone graft in skeletally mature patients. The lumbar IBF implantsare intended for use at either one level or two contiguous levels in the lumbarspine, from L2 to S1, for the treatment of degenerative disc disease (DDD) |
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510(k) Summary
with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (Tl to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Capri Corpectomy Cage System
CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
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K221490 Page 18 of 21 Traditional 510(k) MRI Compatibility – IBD and Corpectomy Systems
510(k) Summary
When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
Cascadia Interbody System
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
Chesapeake Stabilization System
When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
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510(k) Summary
When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).
Mojave Expandable Interbody System
The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Sahara Stabilization System
The SAHARA Stabilization System implants are intervertebral body fusion. devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared
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| 510(k) Summary | |
|---|---|
| for use in the lumbar spine, in addition to the bone screws provided.Additional supplemental fixation (i.e. pedicle screw and rod system) isneeded when used as an adjunct to fusion for degenerative scoliosis.Otherwise, the SAHARA Stabilization System implants may be used as astand-alone device, which is intended to be used with the bone screwsprovided. | |
| Santorini Corpectomy Cage SystemSANTORINI Corpectomy Cages are vertebral body replacement devicesintended for use in the cervical and thoracolumbar spine. | |
| When used in the cervical spine (C2-T1), SANTORINI cages are intended foruse in skeletally mature patients to replace a diseased or damaged vertebralbody caused by tumor, fracture, or osteomyelitis, or for reconstructionfollowing corpectomy performed to achieve decompression of the spinal cordand neural tissues in cervical degenerative disorders. These cages areintended to restore integrity of the spinal column even in the absence offusion for a limited time period in patients with advanced stage tumorsinvolving the cervical spine in whom life expectancy is of insufficient durationto permit achievement of fusion, with bone graft used at the surgeon'sdiscretion. | |
| When used in the thoracolumbar spine (T1-L5), SANTORINI cages areintended for use to replace a collapsed, damaged, or unstable vertebral bodydue to tumor and trauma (i.e. fracture). These cages are designed to provideanterior spinal column support even in the absence of fusion for a prolongedperiod. | |
| The interior of the cages can be packed with autograft or allogenic bone graftcomprising cancellous and/or corticocancellous bone graft as an adjunct tofusion. | |
| When used in the thoracolumbar spine, the Santorini Corpectomy cages areintended to be used with supplemental internal fixation appropriate for theimplanted level, including K2M Pedicle Screw and Hook Systems, and K2MSpinal Plate Systems. | |
| When used in the cervical spine at one or two levels, the SANTORINICorpectomy Cage System is intended to be used with supplemental fixationcleared by the FDA for use in the cervical spine. When used at more than twolevels, supplemental fixation should include posterior fixation which iscleared by the FDA. | |
| Summary of theTechnologicalCharacteristics | The devices in this submission possess the same technologicalcharacteristics as their predicate devices; no changes have been made to anyof the devices. Therefore, the fundamental scientific technology of the |
| Summary of thePerformance Data | MR Compatibility testing per ASTM F2503-13 was performed. The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and is substantially equivalent to the predicate devices. |
| Conclusion | The subject devices possess the same intended use and technological characteristics as the predicate devices. Therefore, the subject devices are substantially equivalent. |
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K221490 Page 21 of 21 Traditional 510(k) MRI Compatibility – IBD and Corpectomy Systems
510(k) Summary
§ 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.