# K111550: Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia, Yyy=Length- in MM)

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedic Products, Inc.
- Decided: Aug 19, 2011 after 77 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.
No later device cites it as a predicate yet.
0 of 6 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) Ensplint CMX: named in the summary without a submission number

## Indications for use
The Sonoma FasTrac 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/K111550
Methodology: https://510kreport.com/methodology