# K141665: NuVasive CoRoent System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Mar 13, 2015 after 263 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). 132 ancestors in all.
588 later devices descend from it; 18 cite it directly.
1 of 721 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 4.
- K113348: Cougar System, Johnson & Johnson (2011) Summary page 4.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.
- K130820: Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2013) Summary page 4.
- K131082: Interform Interbody Cage System, Next Orthosurgical (2013) Summary page 4.
- K132601: Coroent Sterile Implants System, Nu Vasive, Incorporated (2013) Summary page 4.
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 4.
- K140319: Coroent TI-C System, Nuvasive, Inc. (2014). Cleared while this submission was under review Summary page 4.
- K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic, Pioneer Surgical Technology, Inc. (2014) Summary page 4.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 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 System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. 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) 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 (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.

Source page: https://510kreport.com/device/K141665
Methodology: https://510kreport.com/methodology