# K173892: NuVasive® XLX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: May 4, 2018 after 134 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: 21 generations back to K841189 (1984). 272 ancestors in all.
115 later devices descend from it; 3 cite it directly.
1 of 388 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172123: NuVasive® Modulus XLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K171633: NuVasive TLX Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K140770: MLX - Medial Lateral Expandable Lumbar Interbody System, Nu Vasive, Incorporated (2014) Summary page 4.
- K161230: NuVasive Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.
- K163506: Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System, Vertera, Inc. (2017) Summary page 4.

## Most influential descendants
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Indications for use
The NuVasive XLX 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. When used with or without the XLX internal fixation, the system is intended for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. XLX interbody devices expanded to ≥20° lordosis must be used with the XLX internal fixation and additional supplemental fixation. The devices are to be used in patients who have had at least six months of non-operative treatment. The XLX 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 XLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K173892
Methodology: https://510kreport.com/methodology