# K153419: NuVasive CoRoent Thoracolumbar System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Apr 13, 2016 after 140 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: 16 generations back to K841189 (1984). 164 ancestors in all.
400 later devices descend from it; 6 cite it directly.
0 of 565 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151472: NuVasive CoRoent Lumbar System, Nu Vasive, Incorporated (2015) Summary page 4.
- K150994: NuVasive CoRoent Thoracolumbar Implants, Nu Vasive, Incorporated (2015) Summary page 4.

## Most influential descendants
- 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
- K171633: NuVasive TLX Interbody System (2017), 251 descendants of its own

## Indications for use
The NuVasive CoRoent Thoracolumbar 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 and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to 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. The CoRoent Thoracolumbar System (XL and L platforms) implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K153419
Methodology: https://510kreport.com/methodology