# K103666: Lanx Lateral

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Mar 23, 2011 after 98 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: 7 generations back to K841189 (1984). 28 ancestors in all.
238 later devices descend from it; 5 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083815: Lanx Fusion System, Lanx, Inc. (2009) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K052210: Nuvasive Coroent Extensure System, Nuvasive, Inc. (2005) Summary page 1.

## Most influential descendants
- K133557: Juliet LL Lateral Lumbar Cage (2014), 147 descendants of its own
- K141135: Juliet LL (2014), 146 descendants of its own
- K161888: JULIET® LL Lateral Lumbar Cage (2016), 145 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (2020), 130 descendants of its own

## Indications for use
When used as a lumbar intervertebral body fusion device; the Lanx Fusion System - Lateral ("Lanx Lateral') is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD') at one or two contiguous spinal levels from L2-SJ. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lain Lateral is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System. When used as vertebral body replacement, the Lanx Fusion System - Lateral ("Lain Lateral') is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine from Ti to LS) The Lain Lateral may also be used in the thoracolumbar spine (i. e., Ti - LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lain Lateral is also indicated for treating fractures of the thoracic and lumbar spine. The Lain Lateral is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system

Source page: https://510kreport.com/device/K103666
Methodology: https://510kreport.com/methodology