# K171633: NuVasive TLX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Sep 28, 2017 after 118 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: 20 generations back to K841189 (1984). 204 ancestors in all.
251 later devices descend from it; 9 cite it directly.
0 of 456 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170962: NuVasive® CoRoent® Thoracolumbar System, Nu Vasive, Incorporated (2017). Cleared while this submission was under review Summary page 4.
- K153627: NuVasive® TLX Interbody System, Nu Vasive, Incorporated (2016) Summary page 4.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 4.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 4.
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.
- K140770: MLX - Medial Lateral Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2014) Summary page 4.

## Most influential descendants
- 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
- K180480: ATEC Universal Spacer System (2018), 113 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 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. The devices are to be used in patients who have had at least six months of non-operative treatment. The TLX 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 TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K171633
Methodology: https://510kreport.com/methodology