# K141896: Coroent System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 20, 2014 after 129 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: 14 generations back to K841189 (1984). 78 ancestors in all.
480 later devices descend from it; 2 cite it directly.
0 of 559 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 4.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 4.
- K132601: Coroent Sterile Implants System, Nu Vasive, Incorporated (2013) Summary page 4.
- K140659: Coroent Thoracolumbar Implants, Nu Vasive, Incorporated (2014) Summary page 4.

## Most influential descendants
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- 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

## Indications for use
The NuVasive CoRoent 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 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 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/K141896
Methodology: https://510kreport.com/methodology