# K162944: Irix-C Cervical Integrated Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Nov 7, 2016 after 17 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: 16 generations back to K003155 (2001). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131951: Irix-C Cervical Integrated Fusion System, X-Spine Systems, Inc. (2013) Summary page 5.
- K161280: Cervical Stand Alone System, Orthofix, Inc. (2016) Summary page 5.

## Most influential descendants
- K173832: InTice™-C Porous Ti Cervical Interbody System (2018), 0 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 (C2 – 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 autograft and/or allograft comprised of cancellous and/or corticocancellous 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/K162944
Methodology: https://510kreport.com/methodology