# K120918: Nuvasive Coroent Titanium System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Jun 28, 2012 after 93 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: 2 generations back to K071922 (2007). 2 ancestors in all.
642 later devices descend from it; 12 cite it directly.
1 of 645 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.

## Most influential descendants
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K140659: Coroent Thoracolumbar Implants (2014), 483 descendants of its own
- 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

## Indications for use
Intervertebral Body Fusion The NuVasive CoRoent Titanium 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 Titanium System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 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 that are cleared by the FDA for use in the lumbar spine. Partial Vertebral Body Replacement The NuVasive CoRoent Titanium System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (Ti 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 System is intended to be used with supplemental internal spinal fixation systems 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/K120918
Methodology: https://510kreport.com/methodology