# K100112: Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedic Products, Inc.
- Decided: Sep 28, 2010 after 257 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903258 (1990). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081832: Ensplintcmx Clavicle Pin, Sonoma Orthopedic Products, Inc. (2008) Summary page 1.
- K991649: Depuy Rockwood Clavicle Pin, Depuy, Inc. (1999) Summary page 1.
- (no number) Sonoma CRx WG: named in the summary without a submission number

## Most influential descendants
- K163488: Flex-Thread Clavicle Pin System (2017), 1 descendant of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Indications for use
The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Source page: https://510kreport.com/device/K100112
Methodology: https://510kreport.com/methodology