# K161442: NuVasive® CoRoent® Small Interlock™ System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Sep 28, 2016 after 126 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). 130 ancestors in all.
94 later devices descend from it; 2 cite it directly.
0 of 225 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.
- K102547: Coroent Interlock System, Nuvasive, Inc. (2011) Summary page 4.
- K140921: Coroent Small Interbody System, Nu Vasive, Incorporated (2014) Summary page 4.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 4.
- K131025: Archon Anterior Cervical Plate System, Nuvasive, Inc. (2013) Summary page 4.

## Most influential descendants
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K180909: REVEL Spacers (2018), 37 descendants of its own
- K191243: HEDRON Cervical Spacers (2019), 36 descendants of its own
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own
- K190885: Elevation Spine Saber-C System (2019), 25 descendants of its own

## Indications for use
The NuVasive CoRoent Small Interlock 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 NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock 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/K161442
Methodology: https://510kreport.com/methodology