# K123093: Stabilink Mis Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Spine, LLC
- Decided: Dec 20, 2012 after 79 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K033826 (2004). 15 ancestors in all.
6 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)
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 1.
- K083581: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 1.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (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.
- K121940: Lanx Spinal Fixation System, Lanx, Inc. (2012) Summary page 1.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- 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
- K160568: Precision Spine Interspinous Plate System (2016), 0 descendants of its own

## Indications for use
The StabiLinkTM MIS Spinal Fixation System 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 (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); tumor. It is not intended for stand-alone use.

Source page: https://510kreport.com/device/K123093
Methodology: https://510kreport.com/methodology