# K071633: Lanx Deformity System

- Pathway: 510(k) (Special)
- Applicant: Lanx, LLC
- Decided: Aug 15, 2007 after 62 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033826 (2004). 2 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043484: Lanx Spinal Fixation System, Lanx, LLC (2005) Summary page 1.

## Most influential descendants
- K103237: Lanx Spinal System (2011), 18 descendants of its own
- K090252: Modification to: Lanx Spinal Fixation System (2009), 18 descendants of its own
- K120399: Lanx Spinal Fixation System (2012), 17 descendants of its own
- K121940: Lanx Spinal Fixation System (2012), 8 descendants of its own
- K122145: Lanx Spinal Fixation System (2012), 7 descendants of its own

## Indications for use
The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in sheletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K071633
Methodology: https://510kreport.com/methodology