# K112923: Suspension Clavicle Fracture Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Suspension Orthopaedic Solutions, LLC
- Decided: Dec 27, 2011 after 85 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: 9 generations back to K962616 (1996). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102095: Suspension Clavicle Fracture Fixation System, Suspension Orthopaedic Solutions, LLC (2010) Summary page 1.

## Indications for use
The Suspension TM Clavicle Fracture Fixation System can be used for adult patients. The Suspension TM Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures. For lateral clavicle fractures, the Suspension TM Clavicle Fracture Fixation System may also be used with the Suspensionn' Acramnioclavicular (AC) Repair System.

Source page: https://510kreport.com/device/K112923
Methodology: https://510kreport.com/methodology