AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX

K101051•MAX•8/12/2010

Applicant

STRYKER SPINE

Intended Use

The Stryker Spine AVS® A-LAT 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® A-LAT PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Indications for Use

The Stryker Spine AVS® A-LAT 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® A-LAT PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Predicate Devices

  • P960025 - DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System (MAX)
  • K082014 - Stryker Spine AVS® PL PEEK Spacers (MAX)
  • K093242 - Globus PATRIOT® Transcontinental® Spacer (MAX)
  • K083661 - Stryker Spine AVS® TL PEEK Spacers (MAX)
  • K071795 and K081611 - NuVasive CoRoent® XL Spacers (MAX)