# K210439: NuVasive MOD-EX XLIF Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: May 12, 2021 after 89 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: 24 generations back to K841189 (1984). 293 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 298 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Nu Vasive, Incorporated (2020) Summary page 4.
- K173892: NuVasive® XLX Interbody System, Nu Vasive, Incorporated (2018) Summary page 4.
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.
- K181860: NuVasive Cohere Thoracolumbar Interbody System, Nu Vasive, Incorporated (2018) Summary page 4.
- K163230: NuVasive Modulus XLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K221894: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (2023), 2 descendants of its own
- K220478: NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System (2022), 2 descendants of its own
- K253401: SCRIPT™ Implant System (2026), 0 descendants of its own
- K234035: COSINE™ Spacer (2024), 0 descendants of its own

## Indications for use
The NuVasive MOD-EX XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. When used with or without the MOD-EX XLIF internal fixation, the system is intended 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. When >20° lordosis is needed, the plated MOD-EX XLIF interbody must be used along with additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment. The MOD-EX XLIF Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is 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 NuVasive MOD-EX XLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

Source page: https://510kreport.com/device/K210439
Methodology: https://510kreport.com/methodology