# K043484: Lanx Spinal Fixation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Lanx, LLC
- Decided: May 16, 2005 after 150 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033826 (2004). 1 ancestor in all.
77 later devices descend from it; 6 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033826: Orthopedic Alliance Spine System, Orthopedic Alliance, LLC (2004) Summary page 1.

## Most influential descendants
- K071877: Lanx Spinal Fixation System (2007), 75 descendants of its own
- K100354: Primal OK Interspinous Fusion System (2010), 37 descendants of its own
- K102195: SP-Fix Spinous Process Fixation Plate (2011), 32 descendants of its own
- K131238: Affix Spinous Process Plate System (2013), 30 descendants of its own
- K071633: Lanx Deformity System (2007), 29 descendants of its own

## Indications for use
The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally 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/K043484
Methodology: https://510kreport.com/methodology