# K160222: OIC Cervical PEEK Spacer

- Pathway: 510(k) (Traditional)
- Applicant: The Orthopaedic Implant Company
- Decided: Dec 7, 2016 after 313 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: 11 generations back to K841189 (1984). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092540: C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer, Rsb Spine, LLC (2010) Summary page 4.
- K111272: Rhausler Plage Anterior Cervical Fusion System, Rhausler, Inc. (2011) Summary page 4.

## Indications for use
The Cervical PEEK Spacer is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Cervical PEEK Spacer is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical PEEK Spacer is intended to be used with a supplemental internal fixation system.

Source page: https://510kreport.com/device/K160222
Methodology: https://510kreport.com/methodology