# K140921: Coroent Small Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jul 28, 2014 after 109 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 12 generations back to K841189 (1984). 43 ancestors in all.
444 later devices descend from it; 3 cite it directly.
0 of 488 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 1.
- K140003: Coroent Small Interbody System, Nuvasive, Inc. (2014) Summary page 1.
- K130177: Anatomic Peek Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 1.

## Most influential descendants
- K150362: NuVasive CoRoent Small Interbody System (2015), 441 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163491: NuVasive CoRoent Small Interbody System (2017), 289 descendants of its own
- K162264: Cascadia Interbody System (2016), 169 descendants of its own
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages (2017), 159 descendants of its own

## Indications for use
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/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/K140921
Methodology: https://510kreport.com/methodology