# K220478: NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jun 21, 2022 after 123 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: 25 generations back to K841189 (1984). 319 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 322 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210439: NuVasive MOD-EX XLIF Interbody System, Nu Vasive, Incorporated (2021) Summary page 4.
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 4.
- K163230: NuVasive Modulus XLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K130868: Nuvasive Decade Lateral Plate System, Nuvasive, Inc. (2013) Summary page 4.
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.

## Most influential descendants
- 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 or a bone void filler as cleared by FDA for use in intervertebral body fusion 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 NuVasive MOD-EX XLIF Plated 2.0 Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft or a bone void filler as cleared by FDA for use in intervertebral body fusion 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 MOD-EX XLIF Interbody System and MOD-EX XLIF Plated 2.0 Interbody System are 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 and NuVasive MOD-EX XLIF Plated 2.0 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/K220478
Methodology: https://510kreport.com/methodology