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The Stryker Spine AVS® ALign PEEK Spacers are intervertebral body fusion devices 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 I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach. The AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

This Special 510(k) premarket notification is intended to introduce the new sizes to the AVS® AL PEEK Spacer family cleared under K090166. Note that the AVS® ALign PEEK Spacers may also be referred to as AVS® AL spacers. The Stryker Spine AVS® ALign PEEK Spacers are intervertebral body fusion devices 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 I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach. The AVS® ALign PEEK Spacers are intended to be used with supplemental fixation plate and rod systems that have been cleared for use in the lumbosacral spine. Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS® ALign PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.

The provided text describes a Special 510(k) premarket notification for modifications to an intervertebral body fusion device, the AVS® ALign PEEK Spacer System. This filing is primarily to introduce new sizes to an existing device family cleared under K090166.

The document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria. It explicitly states that "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS® ALign PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems." This indicates that the device's performance was evaluated against a guidance document and found to be substantially equivalent to predicates, but it does not detail specific acceptance criteria or the results of the specific performance tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets these criteria. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results against specific, quantifiable acceptance criteria.

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