# K140003: Coroent Small Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Apr 3, 2014 after 91 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: 11 generations back to K841189 (1984). 41 ancestors in all.
453 later devices descend from it; 5 cite it directly.
0 of 495 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.
- K123206: Maxim Surgical X-Treme Interbody Fusion System, Maxim Surgical (2013) Summary page 1.
- K083118: Spinal Usa Anterior Cervical Interbody Fusion Device, Spinal USA (2009) Summary page 1.

## Most influential descendants
- K142050: Nuvasive Coroent Small Contoured Interbody System (2014), 449 descendants of its own
- K140921: Coroent Small Interbody System (2014), 444 descendants of its own
- 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

## Indications for use
Intervertebral Body Fusion The NuVasive CoRoent Small Interbady 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 degenerative disc disease (DDD) at one level from C2 - TI. 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 designed for use with autogenous 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. Partial Vertebral Body Replacement The NuVasive CoRoent Small Interbody, System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T I to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allografi or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K140003
Methodology: https://510kreport.com/methodology