# K100944: Clavicle Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Oct 22, 2010 after 199 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: 8 generations back to K962616 (1996). 31 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 3.
- K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity, Smith & Nephew, Inc. (2006) Summary page 1.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 1.
- K050852: Claviculaplate with Angular Stablity Bone Plate System, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 1.

## Most influential descendants
- K130774: Universal Distal Radius System (2013), 5 descendants of its own
- K142502: Alians Ulna Locking Plating System (2014), 2 descendants of its own
- K211592: Avanti Orthopaedics Ulnar Shortening System (2021), 1 descendant of its own
- K170843: Alians Fragment Specific (2017), 1 descendant of its own
- K112509: Trimed Clavicle Fixation System (2011), 1 descendant of its own

## Indications for use
The implants of the Clavicle Locking Plating System are indicated for fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

Source page: https://510kreport.com/device/K100944
Methodology: https://510kreport.com/methodology