# K120651: Stabiliz Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stabiliz Orthopaedics, LLC
- Decided: Nov 27, 2012 after 270 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: 2 generations back to K000684 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 2.
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006)

## Most influential descendants
- K130731: Stabiliz Fixation System - SPL Locking Screw (2013), 0 descendants of its own

## Indications for use
The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

Source page: https://510kreport.com/device/K120651
Methodology: https://510kreport.com/methodology