# K100865: Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Aug 11, 2010 after 135 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: 7 generations back to K010530 (2001). 14 ancestors in all.
637 later devices descend from it; 2 cite it directly.
0 of 652 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.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 1.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 1.
- K080758: Avs PL Peek Spacers, Models 48351 and 48353, Stryker Corp. (2008) Summary page 1.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 1.

## Most influential descendants
- 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
- K161230: NuVasive Lumbar Interbody Implants (2016), 381 descendants of its own

## Indications for use
The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative ditc disease (DOD) at one level or two contiguous levels from L2 to Si. ODDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DODD 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® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach. The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K100865
Methodology: https://510kreport.com/methodology