# K202812: IdentiTi Cervical Standalone Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Dec 18, 2020 after 85 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: 25 generations back to K841189 (1984). 466 ancestors in all.
67 later devices descend from it; 3 cite it directly.
1 of 534 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System, Nexxt Spine, LLC (2020) Summary page 4.
- K170953: Tomcat Cervical Spinal System, Choicespine, LP (2017) Summary page 4.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K214006: Invictus® Spinal Fixation System (2022), 16 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own

## Indications for use
The IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or cortico-cancellous bone and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K202812
Methodology: https://510kreport.com/methodology