# K131951: Irix-C Cervical Integrated Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Aug 14, 2013 after 48 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: 12 generations back to K841189 (1984). 48 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 2.
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 2.
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 2.

## Most influential descendants
- K151934: ROI-C Titanium-Coated Implant System (2015), 9 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own

## Indications for use
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of non- operative treatment prior to treatment with a cervical intervertebral fusion device.

Source page: https://510kreport.com/device/K131951
Methodology: https://510kreport.com/methodology