# K223837: SPIRA®-C Integrated Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Mar 22, 2023 after 90 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: 26 generations back to K841189 (1984). 968 ancestors in all.
No later device cites it as a predicate yet.
4 of 969 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172446: SPIRA-C Open Matrix Cervical Interbody, Camber Spine Technologies (2017) Summary page 5.
- K193153: SPIRA-C Integrated Fixation System, Camber Spine Technologies (2020) Summary page 5.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 5.
- K202065: DOLOMITE Anterior Cervical Stabilization System, Astura Medical, LLC (2020) Summary page 5.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 5.

## Indications for use
The SPIRA@-C Integrated Fixation System is intended for use as a cervical intervertebral fusion system indicated for use at one or two contiguous levels in the cervical spine (C2-T1), in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, kyphosis, or lordosis), pseudarthrosis, and failed previous fusion. The device is intended for use with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. When used with screws, SPIRA@-C Integrated Fixation System are standalone interbody fusion devices intended for use at one or two contiguous levels in the cervical spine (C2-T1). When used with anchors, SPIRA9-C Integrated Fixation System is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

Source page: https://510kreport.com/device/K223837
Methodology: https://510kreport.com/methodology