# K083581: Lanx Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Lanx, Inc.
- Decided: Apr 7, 2009 after 124 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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
No predicates in its family tree.
21 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lanx Spinal Fixation System: named in the summary without a submission number

## Most influential descendants
- K103237: Lanx Spinal System (2011), 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
- K123093: Stabilink Mis Spinal Fixation System (2012), 6 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, not intended for stand-alone use.

Source page: https://510kreport.com/device/K083581
Methodology: https://510kreport.com/methodology