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The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at multiple contiguous levels (C2 to T1) 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. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK cervical implant system is intended to be used with a supplemental fixation system. Additionally, the use of hyperlordotic devices (lordotic angle greater than 8°) are intended to be used exclusively with anterior supplemental fixation.

Matrix HA PEEK Cervical IBF devices are manufactured from Hydroxyapatite (HA) filled Polyetheretherketone (PEEK). The specific material is PEEK-OPTIMA HA Enhanced manufactured by Invibio. The Matrix HA Cervical IBF Devices superior and inferior surfaces have ridges designed to interface with the vertebral endplates to help resist rotation and migration. Tantalum (ASTM F560) or titanium (ASTM F136) rods are located at the extremes of the Matrix HA Cervical IBF Devices to allow for radiological confirmation of the device positioning. The anterior face of each interbody has a recessed horizontal slot encapsulating a 6/32 threaded thru hole which is to be used to interface with the inserter. Each device has a uniform wall thickness of 2.5mm. Matrix HA PEEK Cervical IBF Devices are available in multiple configurations to coincide with the surgical approach and patient needs: parallel, 7° thru 20° lordotic angle and convex. The Matrix HA PEEK Cervical IBF Devices are open rectangular devices with curved lateral walls and rounded edges. The devices are open with cavities to facilitate bony ingrowth.

The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at one level (C2 to T1) 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. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK Cervical Implant System is intended to be used with a supplemental fixation system.

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The SMG Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions 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), - · failed previous fusion (pseudoarthrosis) - · spinal stenosis.

The SMG Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6Al-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and selfdrilling threaded. This device is provided as non-sterile.

The Cervical Implant is intended for spinal fusion procedures at one level (C2 to T1) 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. Implants are intended via an open, anterior approach and packed with autogenous bone graft. The Cervical Implant is intended to be used with supplemental fixation system.

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The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The A-Wedge Anterior Interbody System (A-Wedge AIS) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. A-Wedge AIS implants are available in two lordotic configurations (6° and 11°) of various heights to restore lumbar lordosis and the associated sagittal balance. SMG A.I.S. implants have three titanium alloy x-ray markers. The A-Wedge AIS device is single-use only. Materials: Medical grade PEEK (ASTM F2026) machined from Orthoplastics Vertepeek extruded bar stock (FDA master file MAF #1820). Orthoplastics Vertepeek is fabricated from Evonik Degussa medical grade Vestakeep | PEEK granules (FDA master file MAF # 1688). ELI grade titanium alloy (Ti-6Al-4V per ASTM F136) for radio opaque markers. Function: A-Wedge AIS devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.