# K153782: NuVasive® Lumbar Interbody Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Mar 24, 2016 after 84 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: 17 generations back to K841189 (1984). 172 ancestors in all.
390 later devices descend from it; 5 cite it directly.
0 of 563 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 5.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 5.
- K140319: Coroent TI-C System, Nuvasive, Inc. (2014) Summary page 5.
- K131723: Coroent Single Tab System, Nuvasive, Inc. (2013) Summary page 5.
- K140479: Coroent XL-F System, Nu Vasive, Incorporated (2014) Summary page 5.
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 5.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 5.

## Most influential descendants
- 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
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own

## Indications for use
NuVasive® Lumbar Non-Interfixated Interbody Implants: The NuVasive Lumbar Non-Interfixated Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-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. NuVasive® Lumbar Interfixated Interbody Implants: The NuVasive Lumbar Interfixated Interbody Implants, including CoRoent Single Tab System, CoRoent XL-F System, Brigade Standalone System, and Brigade Hyperlordotic System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment. The Lumbar Interfixated Interbody Implants are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1 for Brigade Systems and L2-L5 for CoRoent Single Tab and XL-F) 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. CoRoent Single Tab System, CoRoent XL-F System, and Brigade Hyperlordotic System are intended to be used with supplemental fixation systems that that are cleared by the FDA for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K153782
Methodology: https://510kreport.com/methodology