# K160051: NuVasive® Interfixated Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Apr 20, 2016 after 100 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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). 177 ancestors in all.
396 later devices descend from it; 2 cite it directly.
0 of 574 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140479: Coroent XL-F System, Nu Vasive, Incorporated (2014) Summary page 4.
- K131723: Coroent Single Tab System, Nuvasive, Inc. (2013) Summary page 4.
- K100043: Coroent XLR Standalone System, Nuvasive, Inc. (2010) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.
- K153419: NuVasive CoRoent Thoracolumbar System, Nu Vasive, Incorporated (2016). Cleared while this submission was under review Summary page 4.

## 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
The NuVasive® Interfixated Interbody System is indicated for the following: CoRoent XL-F System The NuVasive CoRoent XL-F 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 (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. Brigade System The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous 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 Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Source page: https://510kreport.com/device/K160051
Methodology: https://510kreport.com/methodology