# K071877: Lanx Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, LLC
- Decided: Sep 17, 2007 after 70 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: 2 generations back to K032037 (2003). 4 ancestors in all.
75 later devices descend from it; 18 cite it directly.
0 of 80 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.
- K043053: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.

## Most influential descendants
- 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
- K133052: Affix (R) Next Gen Spinous Process Plate System (2013), 18 descendants of its own
- K130438: Axle Interspinous Fusion System (2013), 18 descendants of its own

## Indications for use
The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Lanx SFS 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). The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K071877
Methodology: https://510kreport.com/methodology