# K162138: NuVasive CoRoent Small Ti-C System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Oct 26, 2016 after 86 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: 19 generations back to K841189 (1984). 190 ancestors in all.
135 later devices descend from it; 3 cite it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150362: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2015) Summary page 4.
- K160916: CoRoent® Ti-C System, Nu Vasive, Incorporated (2016) Summary page 4.
- K140319: Coroent TI-C System, Nuvasive, Inc. (2014) Summary page 4.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 4.

## Most influential descendants
- K172676: NuVasive® Modulus-C Interbody System (2017), 125 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own

## Indications for use
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are 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/K162138
Methodology: https://510kreport.com/methodology