# K161230: NuVasive Lumbar Interbody Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Aug 25, 2016 after 115 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: 18 generations back to K841189 (1984). 199 ancestors in all.
381 later devices descend from it; 16 cite it directly.
0 of 581 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153782: NuVasive® Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 5.
- K141896: Coroent System, Nu Vasive, Incorporated (2014) Summary page 5.
- K153419: NuVasive CoRoent Thoracolumbar System, Nu Vasive, Incorporated (2016) Summary page 5.
- K160051: NuVasive® Interfixated Interbody System, Nu Vasive, Incorporated (2016) Summary page 5.

## Most influential descendants
- 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
- K170592: NuVasive BASE Interfixated Titanium System (2017), 186 descendants of its own

## Indications for use
NuVasive® Lumbar Non-Interfixated Interbody Implants: The NuVasive Lumbar Interbody Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is 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 systems 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. The Lumbar Interbody Implants (XL platform) are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the Lumbar Interbody Implants (XL and L platforms) are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Lumbar Interbody Implants (XL and L platforms) are also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine. NuVasive® Lumbar Interfixated Interbody Implants: CoRoent XL-F System: The NuVasive Lumbar Interbody Implants (CoRoent XL-F platform) are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and 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. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent XL-F platform implants are 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) or degenerative 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 platform implants can also be used as an adjunct for fusion in patients diagnosed with multilevel degenerative scoliosis. Brigade System: The NuVasive Lumbar Interbody Implants (Brigade System platform) are 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., posterior pedicle screw and rod 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 and/or allogeneic 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 Interbody Implants (Brigade System platform) are 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) or degenerative 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 platform implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. However, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the Brigade System platform 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/K161230
Methodology: https://510kreport.com/methodology