# K031677: Synthes (Usa) Calvicle Hook Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 21, 2003 after 83 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 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 Small T- Plate: named in the summary without a submission number
- (no number) Synthes LCP T-Plate: named in the summary without a submission number
- (no number) Howmedica’s Bosworth Screw: named in the summary without a submission number

## Most influential descendants
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws (2018), 4 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K243995: Arthrex Humeral Plating System and Cerclage Button (2025), 1 descendant of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant 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/K031677
Methodology: https://510kreport.com/methodology