# K151496: Latitude-C Cervical Interbody Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Dec 15, 2015 after 195 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: 15 generations back to K003155 (2001). 90 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System, Orthofix, Inc. (2015) Summary page 4.

## Most influential descendants
- K181261: Curiteva Cervical Interbody Fusion System (2018), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K213030: Curiteva Porous PEEK Cervical Interbody Fusion System (2023), 3 descendants of its own
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own
- K252894: aprevo® cervical interbody system (2026), 1 descendant of its own

## Indications for use
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level 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 Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C 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 Interbody Spacer in the cervical spine.

Source page: https://510kreport.com/device/K151496
Methodology: https://510kreport.com/methodology