# K151472: NuVasive CoRoent Lumbar System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Sep 10, 2015 after 101 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 15 generations back to K841189 (1984). 162 ancestors in all.
479 later devices descend from it; 5 cite it directly.
0 of 642 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141896: Coroent System, Nu Vasive, Incorporated (2014) Summary page 4.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 4.

## Most influential descendants
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own
- K160051: NuVasive® Interfixated Interbody System (2016), 396 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 Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent Lumbar System (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1, 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. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Source page: https://510kreport.com/device/K151472
Methodology: https://510kreport.com/methodology