# K092536: Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Oct 30, 2009 after 72 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
No predicates in its family tree.
21 later devices descend from it; 3 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
- (no number) Stryker Spine Xia 3 Spinal System: named in the summary without a submission number
- (no number) Expedium Spine 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 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.

Source page: https://510kreport.com/device/K092536
Methodology: https://510kreport.com/methodology