# K140479: Coroent XL-F System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jul 28, 2014 after 152 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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: 14 generations back to K841189 (1984). 88 ancestors in all.
465 later devices descend from it; 8 cite it directly.
1 of 554 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131723: Coroent Single Tab System, Nuvasive, Inc. (2013) Summary page 1.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 1.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K160051: NuVasive® Interfixated Interbody System (2016), 396 descendants of its own
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 descendants of its own
- K161230: NuVasive Lumbar Interbody Implants (2016), 381 descendants of its own
- K170962: NuVasive® CoRoent® Thoracolumbar System (2017), 304 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own

## Indications for use
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The CoRoent XL-F System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Source page: https://510kreport.com/device/K140479
Methodology: https://510kreport.com/methodology