# K153627: NuVasive® TLX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Mar 17, 2016 after 90 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: 16 generations back to K841189 (1984). 135 ancestors in all.
252 later devices descend from it; 3 cite it directly.
0 of 388 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143595: NuVasive (R) CCX-L Interbody System, Nu Vasive, Incorporated (2015) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 4.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 4.
- K140770: MLX - Medial Lateral Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2014) Summary page 4.

## Most influential descendants
- K171633: NuVasive TLX Interbody System (2017), 251 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
- K173892: NuVasive® XLX Interbody System (2018), 115 descendants of its own

## Indications for use
The NuVasive® TLX 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 TLX Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, 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 TLX Interbody System. The TLX 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/K153627
Methodology: https://510kreport.com/methodology