# K121316: Lanx Spinal Fization System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Sep 10, 2012 after 131 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 4 generations back to K032037 (2003). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103091: Lanx Spinal Fixation System, Lanx, Inc. (2011) Summary page 1.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.
- K103205: Bridgepoint  Spinous Process Camp- Posterior Fixation System, Alphatec Spine, Inc. (2011) Summary page 1.
- K100354: Primal OK Interspinous Fusion System, Osteomed LP (2010) Summary page 1.
- K102195: SP-Fix Spinous Process Fixation Plate, Globus Medical, Inc. (2011) Summary page 1.
- K102020: Vega Span Spinous Process Plate System, Spinefrontier, Inc. (2010) Summary page 1.

## Most influential descendants
- K131156: Lanx Spinal Fixation System (2013), 1 descendant of its own
- K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (2020), 0 descendants of its own
- K173334: SeaSpine Spinous Process System (2018), 0 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 System is intended for use with autograft or allograft. The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, 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); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level 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/K121316
Methodology: https://510kreport.com/methodology