# K140659: Coroent Thoracolumbar Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jun 26, 2014 after 104 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: 4 generations back to P950002 (1996). 10 ancestors in all.
483 later devices descend from it; 2 cite it directly.
0 of 494 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 1.
- K132601: Coroent Sterile Implants System, Nu Vasive, Incorporated (2013)

## Most influential descendants
- K141896: Coroent System (2014), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 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

## Indications for use
The NuVasive® CoRoent® Thoracolumbar Implants are devices indicated for the following: Intervertebral Body Fusion The NuVasive CoRoent Thoracolumbar Implants are 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 thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. Thoracic Spine: The CoRoent Thoracolumbar Implants are intended for use for thoracic interbody fusions at one or two contiguous levels in the thoracic spine from T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of asymptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar Spine: The CoRoent Thoracolumbar Implants 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. Partial Vertebral Body Replacement The NuVasive CoRoent Thoracolumbar Implants may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 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 implants are intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw system) that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K140659
Methodology: https://510kreport.com/methodology