# K251080: IdentiTi II Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jul 3, 2025 after 86 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: 33 generations back to K841189 (1984). 1,499 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,500 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer, Alphatec Spine (2025) Summary page 5.
- K242364: IdentiTi™ II Interbody System, Alphatec Spine, Inc. (2024) Summary page 5.
- K151496: Latitude-C Cervical Interbody Spacer System, Degen Medical (2015) Summary page 5.
- K150362: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2015) Summary page 5.
- K120603: Varilift -C, Wenzel Spine (2013) Summary page 5.

## Indications for use
The IdentiTi™ II Cervical Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi II Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

Source page: https://510kreport.com/device/K251080
Methodology: https://510kreport.com/methodology