# K090816: Stryker Spine Avs PL Peek Spacers

- Pathway: 510(k) (Special)
- Applicant: Stryker Corp.
- Decided: Apr 24, 2009 after 30 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010530 (2001). 10 ancestors in all.
756 later devices descend from it; 10 cite it directly.
1 of 767 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K080758: Avs PL Peek Spacers, Models 48351 and 48353, Stryker Corp. (2008) Summary page 1.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.

## Most influential descendants
- K100865: Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX (2010), 637 descendants of its own
- K143163: 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 (2015), 636 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own

## Indications for use
The Stryker Spine AVS PL 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 PL PEEK Spacers are to be implanted via posterior approach. The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

Source page: https://510kreport.com/device/K090816
Methodology: https://510kreport.com/methodology