# K203503: Camber Sacroiliac (SI) Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies, LLC
- Decided: Sep 2, 2022 after 641 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K841189 (1984). 124 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 4.
- K173432: ENZA-A Titanium ALIF, Camber Spine Technologies (2018) Summary page 4.

## Most influential descendants
- K233972: Camber Sacroiliac (SI) Fixation System (2024), 1 descendant of its own
- K250247: panaSIa SI Fusion System (2025), 0 descendants of its own

## Indications for use
The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.

Source page: https://510kreport.com/device/K203503
Methodology: https://510kreport.com/methodology