# K061753: Synthes (Usa) Clavicle Hook Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 4, 2006 after 44 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
No predicates in its family tree.
44 later devices descend from it; 18 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) Clavicle Hook Plate: named in the summary without a submission number

## Most influential descendants
- K153716: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (2016), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K140259: Variax Clavicle Hook Plate (2014), 13 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Indications for use
Intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Source page: https://510kreport.com/device/K061753
Methodology: https://510kreport.com/methodology