# K192582: NuVasive CoRoent Small Interlock System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 13, 2019 after 55 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: 15 generations back to K841189 (1984). 119 ancestors in all.
30 later devices descend from it; 5 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142299: CoRoent Small Interlock System, Nu Vasive, Incorporated (2014) Summary page 4.
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K150053: STALIF C; STALIF C-Ti, Centinel Spine, Inc. (2015) Summary page 4.

## Most influential descendants
- K212904: SeaSpine WaveForm C Interbody System (2021), 15 descendants of its own
- K222973: IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem (2022), 13 descendants of its own
- 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
- K233414: Shoreline ACS Interbody System; Shoreline RT Interbody System (2023), 8 descendants of its own
- K213359: SeaSpine WaveForm, C Interbody System (2021), 7 descendants of its own

## Indications for use
The CoRoent Small Interlock System is a standalone anterior cervical interbody fusion system indicated for use 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 System is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K192582
Methodology: https://510kreport.com/methodology