# K210750: Acumed Clavicle Hook Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jul 15, 2021 after 125 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: 12 generations back to K792022 (1979). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140259: Variax Clavicle Hook Plate, Stryker Trauma AG (2014) Summary page 4.
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor, Acumed, LLC (2011) Summary page 4.

## Indications for use
The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions and dislocations of the acromioclavicular joint.

Source page: https://510kreport.com/device/K210750
Methodology: https://510kreport.com/methodology