# K130731: Stabiliz Fixation System - SPL Locking Screw

- Pathway: 510(k) (Traditional)
- Applicant: Stabiliz Orthopaedics, LLC
- Decided: Jul 19, 2013 after 123 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K981372 (1998). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120651: Stabiliz Fixation System, Stabiliz Orthopaedics, LLC (2012) Summary page 2.
- K123918: Motionloc Screw for NCB Polyaxial Locking Plate System, Zimmer, Inc. (2013) Summary page 2.
- K101696: Motionloc Screw for NCB Polyaxial Locking Plating System, Zimmer, Inc. (2010) Summary page 2.
- K020872: Synthes 3.5 MM Broad LC-DCP Plates, Synthes (Usa) (2002) Summary page 2.
- K033233: Lactosorb Tibial L-15 Screw and Washer, Biomet, Inc. (2003) Summary page 2.

## Indications for use
The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.

Source page: https://510kreport.com/device/K130731
Methodology: https://510kreport.com/methodology