# K093704: Avs PL Peek Spacers

- Pathway: 510(k) (Special)
- Applicant: Stryker Corp.
- Decided: Dec 23, 2009 after 22 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: 1 generation back to P960025 (1999). 1 ancestor in all.
713 later devices descend from it; 13 cite it directly.
0 of 715 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- (no number) AVS® PL PEEK Spacers: named in the summary without a submission number

## 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
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own
- K152304: Tritanium PL Cage (2015), 448 descendants of its own
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 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 SI. 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/K093704
Methodology: https://510kreport.com/methodology