# K080758: Avs PL Peek Spacers, Models 48351 and 48353

- Pathway: 510(k) (Special)
- Applicant: Stryker Corp.
- Decided: Mar 27, 2008 after 9 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: 4 generations back to K010530 (2001). 8 ancestors in all.
1,091 later devices descend from it; 6 cite it directly.
1 of 1,100 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.
- 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
- K081395: Solitaire Peek-Optima Anterior Spinal System (2008), 854 descendants of its own
- K082014: Stryker Spine Avs PL Peek Spacers (2008), 837 descendants of its own
- K083475: Lucent Magnum (2009), 834 descendants of its own
- K090816: Stryker Spine Avs PL Peek Spacers (2009), 756 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 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/K080758
Methodology: https://510kreport.com/methodology