# K081832: Ensplintcmx Clavicle Pin

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedic Products, Inc.
- Decided: Oct 10, 2008 after 105 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: 2 generations back to K903258 (1990). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991649: Depuy Rockwood Clavicle Pin, Depuy, Inc. (1999) Summary page 1.

## Most influential descendants
- K100112: Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM) (2010), 2 descendants of its own
- K163488: Flex-Thread Clavicle Pin System (2017), 1 descendant of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own
- K111550: Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia, Yyy=Length- in MM) (2011), 0 descendants of its own

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

Source page: https://510kreport.com/device/K081832
Methodology: https://510kreport.com/methodology