# K101171: Orthovita Peek Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Jan 25, 2011 after 274 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: 1 generation back to K091531 (2009). 1 ancestor in all.
225 later devices descend from it; 2 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)
- K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer, Choice Spine, Llp (2009) Summary page 1.

## Most influential descendants
- K120486: Avs as Peek Spacer (2012), 224 descendants of its own
- 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

## Indications for use
ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

Source page: https://510kreport.com/device/K101171
Methodology: https://510kreport.com/methodology