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The 3D Printed PEEK Interbody System (ALIF) is intended for spinal fusion procedures in the lumbosacral spine at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach. The 3D Printed PEEK Interbody System (Cervical) is intended for spinal fusion procedures in the cervical spine at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.

The 3D Printed PEEK Interbody System devices are spinal fusion implants that are inserted into the intervertebral body space of the spine to act as disc spacers and hold bone graft. These devices are manufactured from PEEK OPTIMA™ LT1AMR5 with tantalum radiographic markers and are offered in multiple footprint, height, and lordotic angle options.

The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.

The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.

The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - · Cotton (opening wedge) Osteotomies of the Medial Cuneiform - · Evans Lengthening Osteotomies - · Subtalar Fusion - · First Metatarsal-Cuneiform Lengthening Arthrodesis - Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular oval and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating, except for the Lapidus and Calcaneocuboid Wedges which will require ancillary fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.

The EARP Interbody System is intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

EARP implants are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

The Quantum Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical fusion in patients with: ·degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), · spondylolisthesis, - · trauma (i.e. fractures or dislocations), - · tumors. - · deformity (defined as kyphosis, lordosis, or scoliosis), - · pseudarthrosis. - · failed previous fusion, - · spinal stenosis.

The Quantum Anterior Cervical Plate is a titanium alloy plate, conforming to ASTM F3001, intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selfdrilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (08 mm - 110 mm), addressing multiple levels of fixation (one to five). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm. and 4.75 mm) and a variety of lengths (10 mm - 20 mm). Screws are made from titanium alloy per ASTM F136.

The Trigon™ HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: - Cotton (opening wedge) osteotomies of the medial cuneiform - . Evans lengthening osteotomies The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.

The nvª, nvª, and nv are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced and include tantalum markers per ASTM F560 for radiographic visualization. The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

The Trigon™ Ti Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as: - Cotton (opening wedge) osteotomies of the medial cuneiform - Evans lengthening osteotomies The Trigon Ti wedges are intended for use with ancillary fixation. The Trigon Ti Stand-Alone Wedge Fixation System is not intended for use in the spine.

The Trigon Ti Stand-Alone Wedge Fixation System is a family of additively manufactured titanium wedges used for angular correction of small bones of the foot. The wedges incorporate an organized lattice structure and two screw-receiving holes. The system rectangular and kidney shaped wedges may or may not include a window for containing grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). The associated 2.5mm diameter screws are designed in lengths of 10 to 20mm. When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. When used without the provided screws Trigon wedges are intended for use with ancillary fixation. Windowless wedge designs that do not allow for graft placement should only be used with ancillary plating.

The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nv- devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

The nv& is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.