# K121940: Lanx Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Lanx, Inc.
- Decided: Aug 2, 2012 after 31 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: 5 generations back to K033826 (2004). 14 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 23 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.
- K071633: Lanx Deformity System, Lanx, LLC (2007) Summary page 1.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 1.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K083581: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K092536: Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K093285: Modification to Lanx Spinal Fixation System, Lanx, LLC (2009) Summary page 1.
- K100935: Lanx Spinal Fixation System, Lanx, Inc. (2010) Summary page 1.
- K103091: Lanx Spinal Fixation System, Lanx, Inc. (2011) Summary page 1.
- K103237: Lanx Spinal System, Lanx, Inc. (2011) Summary page 1.
- K120399: Lanx Spinal Fixation System, Lanx, LLC (2012) Summary page 1.

## Cited in the summary but kept off the family tree
- K120682: Lanx Spinal Fixation System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K123093: Stabilink Mis Spinal Fixation System (2012), 6 descendants of its own
- K133363: Interbridge Interspinous Posterior Fixation System (2014), 5 descendants of its own
- K142378: Interspinous Plate System (2014), 3 descendants of its own
- K151863: Precision Spine Interspinous Plate System (2015), 2 descendants of its own
- K160465: Spinal Elements' Spinous Process Plate System (2016), 0 descendants of its own

## Indications for use
The Lain Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fulsion of the thoracic, lumbar and/or sacral spine. The system is intended for use with autograt or allograft. The Lain Spinal Fixation System is intended for posterior, non-cervical (TlI-52/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 fuision. The Lain 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 (Tl-S 1). 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 wit degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lain SPFP is intended for use with bone graft material, not intended for stand-alone use.

Source page: https://510kreport.com/device/K121940
Methodology: https://510kreport.com/methodology