# K120486: Avs as Peek Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Aug 20, 2012 after 185 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 2 generations back to K091531 (2009). 2 ancestors in all.
224 later devices descend from it; 7 cite it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101171: Orthovita Peek Spacer, Orthovita, Inc. (2011)

## Most influential descendants
- K142251: AVS AS PEEK Spacer (2014), 161 descendants of its own
- K152532: AERO -C Cervical Cage System (2015), 145 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C1-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and implanted via an open, anterior approach. The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K120486
Methodology: https://510kreport.com/methodology