# K163230: NuVasive Modulus XLIF Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Mar 16, 2017 after 119 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: 19 generations back to K841189 (1984). 231 ancestors in all.
276 later devices descend from it; 11 cite it directly.
1 of 508 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K152304: Tritanium PL Cage, Stryker (2015) Summary page 4.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 4.
- K140319: Coroent TI-C System, Nuvasive, Inc. (2014) Summary page 4.

## Most influential descendants
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K192760: NuVasive Modulus XLIF Interbody System (2019), 163 descendants of its own
- K172341: NuVasive® Modulus TLIF Interbody System (2017), 163 descendants of its own
- K193593: NuVasive 3DP Interfixated ALIF System (2020), 157 descendants of its own
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System (2020), 156 descendants of its own

## Indications for use
The NuVasive Modulus XLIF Interbody System is 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 NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and 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 NuVasive Modulus XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

Source page: https://510kreport.com/device/K163230
Methodology: https://510kreport.com/methodology