# K193153: SPIRA-C Integrated Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Apr 24, 2020 after 163 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 24 generations back to K841189 (1984). 310 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 313 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 4.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 4.
- K133218: Crystal ®; Mosaic ®; Vertu ®, Spinal Elements, Inc. (2014) Summary page 4.
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 4.
- K190870: Cervical Spinal Truss System-Stand Alone (CSTS-SA), 4Web, Inc. (2019) Summary page 4.
- K172446: SPIRA-C Open Matrix Cervical Interbody, Camber Spine Technologies (2017) Summary page 4.

## Most influential descendants
- K253894: BMD Titanium Spinal Fusion System (2026), 0 descendants of its own
- K223837: SPIRA®-C Integrated Fixation System (2023), 0 descendants of its own

## Indications for use
The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The SPIRA-C Integrated Fixation System must be used with internal screw fixation. The Camber Spine Technologies SPIRA-C Integrated Fixation System must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K193153
Methodology: https://510kreport.com/methodology