# K153105: MLX™ - Medial Lateral Expandable Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jul 11, 2016 after 258 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). 113 ancestors in all.
234 later devices descend from it; 3 cite it directly.
0 of 348 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140770: MLX - Medial Lateral Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2014) Summary page 4.
- K130820: Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2013) Summary page 4.
- K151374: NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System, Nu Vasive, Incorporated (2015) Summary page 4.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) 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
- 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
- K200953: NuVasive® Cohere® Thoracolumbar Interbody System (2020), 141 descendants of its own

## Indications for use
The NuVasive® MLX™ – Medial Lateral Expandable Lumbar Interbody 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. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX – Medial Lateral Expandable Lumbar Interbody System. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K153105
Methodology: https://510kreport.com/methodology