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A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space. A-Link Z is 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

The A-Link Z is a spinal device that is implanted in the intervertebral body space to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. The interbody components are manufactured using medical grade polyetheretherketone (PEEK) conforming to ASTM D2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The PEEK version of the interbody comes with two tantalum markers conforming to ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications to facilitate implant placement. The A-Link Z is available in one footprint (36 mm wide). It has an anatomic shape with serrations on the superior and inferior surfaces. The A-Link Z is available in two lordotic angle options (79 and 12°). The 7° lordotic option has heights ranging from 11 mm in 2 mm increments and the 12° lordotic option has heights ranging from 11 mm to 19 mm increments. The interbody comes with a press fit plate manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136. The plate has four screw holes that allow the passage of bone screws. The 5.0 mm and 5.5 mm diameter bone screws are available in three lengths (20 mm, 25 mm and 30 mm). The screws are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136. The A-Link Z is fixed to the adjacent vertebral bodies through the use of four screws inserted through anterior screw holes of the implant. The screws are prevented from backing out after insertion by the attachment of a cover plate and a cover plate screw to the anterior side of the plate. The cover plate and cover plate screw are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136.