# K103237: Lanx Spinal System

- Pathway: 510(k) (Special)
- Applicant: Lanx, Inc.
- Decided: Mar 25, 2011 after 143 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: 3 generations back to K033826 (2004). 10 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 29 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.
- 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.

## Cited in the summary but kept off the family tree
- K090525: Loi System, Palomar Medical Products, Inc. (2009). Our reading of the summary gave K090525, FDA’s number for Loi System (Palomar Medical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lanx Spinal Fixation System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K133363: Interbridge Interspinous Posterior Fixation System (2014), 5 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 (TI-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 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 (TI-SI). 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 Spinous Process Fusion Plate is intended for use with bone graft material, not intended for standalone use.

Source page: https://510kreport.com/device/K103237
Methodology: https://510kreport.com/methodology