# K140770: MLX - Medial Lateral Expandable Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jul 25, 2014 after 120 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: 10 generations back to K841189 (1984). 30 ancestors in all.
269 later devices descend from it; 6 cite it directly.
0 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130820: Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2013) Summary page 1.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 1.

## Most influential descendants
- K143595: NuVasive (R) CCX-L Interbody System (2015), 253 descendants of its own
- K153627: NuVasive® TLX Interbody System (2016), 252 descendants of its own
- K171633: NuVasive TLX Interbody System (2017), 251 descendants of its own
- K151374: NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System (2015), 235 descendants of its own
- K153105: MLX™ - Medial Lateral Expandable Lumbar Interbody System (2016), 234 descendants of its own

## Indications for use
The NuVasive MLX h - 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 NuVasive 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 SI1, for the treatment of degenerative disc disease (IDDD) with up to Grade I spondylolisthesis. DDID 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 NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System. The NuVasive 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/K140770
Methodology: https://510kreport.com/methodology