# K252737: DeGen Medical Latitude-C AM Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Oct 10, 2025 after 43 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: 32 generations back to K841189 (1984). 1,384 ancestors in all.
No later device cites it as a predicate yet.
4 of 1,385 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151496: Latitude-C Cervical Interbody Spacer System, Degen Medical (2015) Summary page 5.
- K240326: Solar™ Lumbar Interbody Fusion System, Degen Medical, Inc. (2024) Summary page 5.
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 5.
- K173128: Alamo® C, Alliance Partners, LLC (2018) Summary page 5.

## Indications for use
The Latitude-C AM™ Interbody Spacer is indicated for spinal fusion procedures at one or more levels in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The Latitude-C AM™ Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Cyclops™ Anterior Cervical Plate System. Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C AM™ Interbody Spacer in the cervical spine.

Source page: https://510kreport.com/device/K252737
Methodology: https://510kreport.com/methodology