AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System

K143163OVD1/26/2015

Applicant

STRYKER CORPORATION

Intended Use

The devices are intended for use as intervertebral body fusion devices with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

Indications for Use

Indicated for use with autograft and/or allogenic bone graft in patients with DDD at one 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. Patients may have up to Grade I spondylolisthesis at involved levels, should be skeletally mature and have six months of nonoperative therapy.

Predicate Devices

  • K093864 - AVS® AL and AVS® ALign PEEK Spacers (MAX)
  • K093704 - AVS® PL and AVS® UniLIF PEEK Spacers (MAX)
  • K083661 - AVS® TL PEEK Spacer (MAX)
  • K100865 - AVS® Navigator PEEK Spacer (MAX)
  • K101051 - AVS® ARIA PEEK Spacer (MAX)
  • K141217 - AccuLIF TL and PL Cage (MAX)
  • K120869 - AVS® Anchor-L Spacer (OVD, MAX)
  • K133328 - Aero-AL Lumbar Cage System (OVD)