# K172446: SPIRA-C Open Matrix Cervical Interbody

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Nov 7, 2017 after 85 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: 15 generations back to K003155 (2001). 83 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133529: Camber Spine Coveris Cervical Cage, Camber Spine (2014) Summary page 4.
- K142112: 4WEB Spinal Implant Products, 4Web, Inc. (2014) Summary page 4.
- K121741: 4-Web Cervical STS (Spinal Truss System), 4-Web, Inc. (2012) Summary page 4.

## Most influential descendants
- K193153: SPIRA-C Integrated Fixation System (2020), 2 descendants of its own
- K222806: Kodiak C Spinal Implant System (2022), 1 descendant of its own
- K253894: BMD Titanium Spinal Fusion System (2026), 0 descendants of its own
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own
- K230851: Kodiak Lumbar Spacer System (2023), 0 descendants of its own

## Indications for use
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K172446
Methodology: https://510kreport.com/methodology