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The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments: - IN1575, Hemi Chisel +3mm, 10mm - IN1576, Hemi Chisel +3mm, 12mm - IN1570, Superior Impactor, Medium - IN1571, Superior Impactor, Large These are new instruments, based on similar devices within the existing instrument set.

The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.

The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.

The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices to be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments.

The STALIF C FLX™ device is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage. The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine. The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The STALIF M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine. The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the treated. These implants may be implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non- fusion spinal surgery at the treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system. The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine. The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine. The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.

The FLXTM Platform is composed of 8 different interbody fusion implant families: - STALIF C FLXTM - STALIF M FLXTM - STALIF L FLXTM and STALIF Lateral-Oblique FLXTM - ACTILIF C FLXTM - ACTILIF M FLXTM - ACTILIF L FLXTM and ACTILIF Lateral-Oblique FLXTM The FLX™ Platform is a novel range of interbody fusion implants with a complex randomized lattice. The Implants retain all of the benefits of the STALIF® product family while taking advantage of the benefits of porous, laser sintered Ti6Al4V. With the recent advances in additive manufacturing, titanium implants are printed with a porous scaffold structure which reduces the stiffness of the device to potentially reduce subsidence and facilitate bone growth through and around the implant. The FLX™ Platform is intended to be implanted between the vertebral bodies into the cleared disc space to help provide stabilization and height restoration and facilitate the interbody fusion process. The device is intended to be used with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The devices are available in a variety of heights, lengths, and widths as well as different lordotic angles to provide surgeons with a wide array of solutions for the highly variable patient population. Surgical instrumentation has been previously developed for the STALIF® Platform and is compatible with the new devices. In addition, interbody-only versions of the FLX™ devices are available in similar size ranges as the STALIF® versions. These devices are not designed to be used with the current STALIF® ABO screw constructs and are instead to be used with supplemental fixation.

The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CENTINEL SPINE PCT 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centinel Spine PCT System consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, and connecting components (e.g., variable and fixed cross connectors). The hooks and polyaxial screws are intended to be attached to the posterior elements of the cervical and/or upper thoracic spine and serve as bone anchors. The rods are longitudinally secured to the bone anchors with the set screw. The various connecting components serve to both secure the construct and provide additional construct configuration options. All implants are manufactured from titanium alloy, Ti6A14V (ASTM F136 or ISO 5832-3)

The STALIF C® and STALIF C-Ti™ devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with titanium alloy screws (Ti6A14V, ASTM F136) and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F560). The STALIF C-Ti™ is identical to this design with a titanium plasma spray coating (CPT) per ASTM F1580) on the device endplates.

The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

STALIF TTTTT, MIDLINE™/ MIDLINE II-Ti™ are radiolucent intervertebral body fusion cages with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF devices are similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. The STALIF devices are manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The MIDLINE II-Ti™ is identical to this design with a titanium plasma spray coating on the device endplates.

The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).

The MIDLINE II™ / MIDLINE II-Ti™ is a radiolucent intervertebral body fusion device manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with three metallic X-ray markers manufactured from unalloyed Tantalum (ASTM F560) and plasma sprayed with optional commercially pure titanium (CPT) per ASTM F1580. The device is secured with titanium (Ti-6A1-4V per ASTM F136) unicortical cancellous bone screws provided and is intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the MIDLINE™ (K133286) to include a titanium coating (ASTM F1580-12) and an additional lordotic option. The MIDLINE II™ / MIDLINE II-Ti™ is provided in 11-21mm heights, 30-42mm widths, 24-30.2mm lengths, and lordotic angles ranging from 8°-20°. The devices are provided sterile.

The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® and STALIF C® Ti are intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.

The STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF C® is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate with central cavity that can be packed with autograft. STALIF C® is manufactured from PEEK-OPTIMA® LTI with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The purpose of this 510(k) was to include a titanium coating (ASTM F1580) on both endplates.