(267 days)
No
The document describes intervertebral body fusion devices and vertebral body replacement devices, which are physical implants. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The purpose of the submission is to establish an MR Conditional labeling claim.
Yes.
Explanation: The devices described are intervertebral body fusion devices and vertebral body replacement devices intended for use in spinal fusion procedures and to restore the integrity of the spinal column, which are therapeutic actions.
No
Explanation: The device is described as an intervertebral body fusion device and spinal vertebral body replacement device, which is an implant used for treatment, not diagnosis. The "Intended Use / Indications for Use" section consistently describes the device for "fusion" or "replacement" in patients with degenerative disc disease or trauma, not for identifying or characterizing a medical condition.
No
The device description explicitly states that the subject devices are "intervertebral body fusion devices and spinal vertebral body replacement devices," which are physical implants. The purpose of the submission is to establish an MR Conditional labeling claim for these physical implants.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes these devices as intervertebral body fusion devices and spinal vertebral body replacement devices. Their purpose is to provide structural support in the spine during fusion or to replace damaged vertebral bodies.
- Mechanism of Action: These devices are implanted surgically to provide mechanical support and facilitate bone fusion. This is a physical intervention within the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The devices described here do not perform such tests on specimens outside the body.
- Device Description: The description reinforces that these are implants designed for surgical placement in the spine.
- Performance Studies: The performance studies mentioned are related to MR compatibility, which is relevant for implanted devices, not IVDs.
Therefore, these devices fall under the category of implantable medical devices rather than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Tritanium® C
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 Tritanium® 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.
Tritanium® PL
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 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® 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.
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 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™ Vertebral Body Replacement System
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 Vertebral Body Replacement System
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 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 Lumbar Cage System
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.
Aero™-LL Lumbar Cage System
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.
Aero®-C Cervical Cage System
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.
AVS® Aria PEEK Spacer
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 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.
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.
AVS® Anchor-C Cervical Cage System
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 C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The 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 Spacer
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 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 used anytime the device is used with any number of screws.
AVS® TL PEEK Spacer / AVS® TL PEEK Spacer 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 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).
AVS® PL PEEK Spacer
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 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.
Additionally, the AVS® PL and AVS® UniLIF™ 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).
AVS® AL PEEK Spacer / AVS® AL Sterile PEEK Spacer
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 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® 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.
AVS® UniLIF PEEK Spacer
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 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.
Additionally, the AVS® PL and AVS® UniLIF™ 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).
AVS® Navigator PEEK Spacer
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 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.
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 PEEK Spacer
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 - 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.
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 (AL 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 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 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.
Aleutian IBF System
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 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.
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 S1, for the treatment of degenerative disc disease (DDD) 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 (T1 to L5) 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.
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.
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 (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 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 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 Cage System
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 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), 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 Hook Systems, 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.
Product codes
ODP, MAX, OVD, MOP, PLR, OVE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2 to T1, C3-C7), Thoracolumbar spine (T1 to L5), Lumbosacral spine (L2 to S1 for lumbar IBF, L2-L5 for specific hyperlordotic implants)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tritanium® C (K171496), 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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.
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
29
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
30
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."
31
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Page 1 of 21
Traditional 510(k)
MRI Compatibility – IBD and Corpectomy Systems
| 510(k) Summary | |
|---|---|
| Submitter: | Stryker Spine |
| 600 Hope Pkwy SE | |
| Leesburg, VA 20175 | |
| Contact Person : | Name: Renee Norby |
| Phone: 201-725-4954 | |
| Email: renee.norby@stryker.com | |
| Date Prepared: | 19-May-2022 |
| Trade Names: | 1. 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® TL PEEK Spacer Sterile
- AVS® PL PEEK Spacer
- AVS® AL/AVS® AL Sterile 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 |
| Common Name: | 1. Tritanium® C
Intervertebral body fusion device - Tritanium® PL
Intervertebral body fusion device - Tritanium® TL
Intervertebral body fusion device |
| | 510(k) Summary |
| 4. | Tritanium® X PL
Intervertebral body fusion device |
| 5. | Tritanium® X TL
Intervertebral body fusion device |
| 6. | VLIFT™
Spinal Vertebral Body Replacement System |
| 7. | VLIFT®-s
Spinal Vertebral Body Replacement Device |
| 8. | Ascential IBD PEEKc Spacer
Cervical Interbody Device |
| 9. | Aero™-AL
Intervertebral fusion device with integrated fixation, lumbar |
| 10. | Aero™-LL
Intervertebral fusion device with integrated fixation, lumbar |
| 11. | Aero®-C
Intervertebral fusion device with bone graft, cervical |
| 12. | AVS® Aria
Intervertebral fusion device with bone graft, lumbar |
| 13. | AVS® Anchor-C
Intervertebral fusion device with bone graft, cervical |
| 14. | AVS® Anchor-L
Intervertebral fusion device with bone graft, lumbar |
| 15. | AVS® TL/AVS® TL Sterile
Intervertebral fusion device with bone graft, lumbar |
| 16. | AVS® PL
Intervertebral fusion device with bone graft, lumbar |
| 17. | AVS® AL/AVS® AL Sterile
Intervertebral fusion device with bone graft, lumbar |
| 18. | AVS® UniLIF
Intervertebral fusion device with bone graft, lumbar |
| 19. | AVS® Nav
Intervertebral fusion device with bone graft, lumbar |
| 20. | AVS® AS
Intervertebral fusion device with bone graft, cervical |
| 21. | Monterey™ AL Interbody System
Intervertebral body fusion device |
| 22. | Aleutian IBF System
Intervertebral body fusion device |
| 23. | Capri Corpectomy Cage System
Vertebral 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® C
Intervertebral Body Fusion Device; 21 CFR §888.3080 |
| | 2. Tritanium® PL
Intervertebral Body Fusion Device; 21 CFR §888.3080 |
| | 3. Tritanium® TL
Intervertebral Body Fusion Device with Bone Graft, Lumbar; 21 CFR §888.3080 |
| | 4. Tritanium® X PL
Intervertebral Body Fusion Device with Bone Graft, Lumbar; 21 CFR §888.3080 |
| | 5. Tritanium® X TL
Intervertebral 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®-s
Spinal Intervertebral Body Fixation Orthosis; 21 CFR §888.3060 |
| | 8. Ascential IBD PEEKc Spacer
Intervertebral Body Fixation Device; 21 CFR §888.3080 |
| | 9. Aero™-AL
Intervertebral body fusion device; 21 CFR §888.3080 |
| | 10. Aero™-LL
Intervertebral body fusion device; 21 CFR §888.3080 |
| | 11. Aero®-C
Intervertebral body fusion device; 21 CFR §888.3080 |
| | 12. AVS® Aria
Intervertebral body fusion device; 21 CFR §888.3080 |
| | 13. AVS® Anchor-C
Intervertebral 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 §888.3080
Intervertebral fusion device with bone graft, cervical; 21 CFR §888.3080
Spinal 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 §888.3080
Intervertebral fusion device with integrated fixation, lumbar; 21 CFR §888.3080
Intervertebral 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 §888.3080
Intervertebral 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® C
ODP |
| | 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 System
PLR, MQP | |
| 24. Cascadia Interbody System
MAX, OVD, ODP | |
| 25. Chesapeake Stabilization System
OVD, OVE | |
| 26. Mojave Expandable Interbody System
MAX | |
| 27. Sahara Stabilization System
OVD, MAX | |
| 28. Santorini Corpectomy Cage System
PLR, 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 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. |
| Intended Use: | Tritanium® C
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 Tritanium® 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. |
| | Tritanium® PL
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 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® 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. |
32
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
34
stryker
35
stryker
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
38
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
39
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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
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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™ LL | |
| 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. | |
| Aero® C | |
| 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. | |
| AVS® Aria | |
| 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 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. | |
| Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to | |
| fusion in patients diagnosed with degenerative scoliosis. | |
| 510(k) Summary | |
| The AVS® ARIA PEEK Spacers are intended to be used with supplemental | |
| fixation systems that have been cleared for use in the lumbosacral spine. | |
| AVS® Anchor C | |
| The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for | |
| anterior cervical interbody fusion procedures in skeletally mature patient | |
| with 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 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). | |
| AVS® PL | |
| 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 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. | |
| Additionally, the AVS® PL and AVS® UniLIF™ 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). | |
| AVS® AL (AVS® AL Sterile) | |
| 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 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. | |
| 510(k) Summary | |
| 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. | |
| AVS® UniLIF | |
| 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 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. | |
| Additionally, the AVS® PL and AVS® UniLIF™ 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). | |
| AVS® Nav | |
| 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 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 |
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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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45
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 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 (AL 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 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 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. |
| Aleutian IBF System |
| 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 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. |
| 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 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) 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 Cage System | |
| 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 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), 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 Hook Systems, 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. | |
| Summary of the | |
| Technological | |
| Characteristics | The devices in this submission possess the same technological |
| characteristics as their predicate devices; no changes have been made to any | |
| of the devices. Therefore, the fundamental scientific technology of the | |
| Summary of the | |
| Performance 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