# K242303: MOD-C

- Pathway: 510(k) (Traditional)
- Applicant: Orthomod, LLC
- Decided: Apr 1, 2026 after 604 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 17 generations back to K003155 (2001). 227 ancestors in all.
No later device cites it as a predicate yet.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171075: Calix-C Cervical Interbody Spacer, X-Spine Systems, Inc. (2017) Summary page 5.
- K181115: CxHA PEEK Cervical IBF System, Innovasis, Inc. (2018) Summary page 5.
- K142264: Valeo C Spacer System, Valeo II C IBF Device, Amedica Corp. (2014) Summary page 5.
- K111264: Cornerstone (R) PSR Cervical Fusion System, Medtronic Sofamor Danek USA (2011) Summary page 5.

## Indications for use
The Orthomod MOD-C™ Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The MOD-C device is to be used with supplemental fixation, such as a cervical plate system. The MOD-C device is designed for use with autogenous and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an anterior approach.

Source page: https://510kreport.com/device/K242303
Methodology: https://510kreport.com/methodology