# K102547: Coroent Interlock System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Feb 7, 2011 after 157 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: 13 generations back to K841189 (1984). 92 ancestors in all.
131 later devices descend from it; 5 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 1.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K094042: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek (2010) Summary page 1.
- K092521: ZUMA-C, Seaspine, Inc. (2010) Summary page 1.
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 1.

## Most influential descendants
- K142299: CoRoent Small Interlock System (2014), 99 descendants of its own
- K161442: NuVasive® CoRoent® Small Interlock™ System (2016), 94 descendants of its own
- 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

## Indications for use
The CoRoent® Small Interlock™ System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CoRoent Small Interlock System. The CoRoent Small Interlock System is intended for use with autograft.

Source page: https://510kreport.com/device/K102547
Methodology: https://510kreport.com/methodology