# K170961: NuVasive CoRoent Small Interlock II System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jun 8, 2017 after 69 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: 20 generations back to K841189 (1984). 256 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161442: NuVasive® CoRoent® Small Interlock™ System, Nu Vasive, Incorporated (2016) Summary page 4.
- K102547: Coroent Interlock System, Nuvasive, Inc. (2011) Summary page 4.
- K142299: CoRoent Small Interlock System, Nu Vasive, Incorporated (2014) Summary page 4.
- K163707: NuVasive CoRoent Ti-C System, Nu Vasive, Incorporated (2017). Cleared while this submission was under review Summary page 4.
- K162138: NuVasive CoRoent Small Ti-C System, Nu Vasive, Incorporated (2016) Summary page 4.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 4.

## Most influential descendants
- K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (2023), 9 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- 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 (2025), 3 descendants of its own

## Indications for use
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K170961
Methodology: https://510kreport.com/methodology