# K955472: Ace Humerus & Radius Plates

- Pathway: 510(k) (Traditional)
- Applicant: Ace Medical Co.
- Decided: Apr 1, 1996 after 123 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.
28 later devices descend from it; 3 cite it directly.
0 of 29 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) DePuy ORIF Small Fragment Plates: named in the summary without a submission number
- (no number) Synthes Small Plates: named in the summary without a submission number
- (no number) Synthes Small Titanium Plates: named in the summary without a submission number

## Most influential descendants
- K143697: Biomet Proximal Humerus Plating System (2015), 17 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own

## Indications for use
The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large. The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length. Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations. bone density and surgeon preference.

Source page: https://510kreport.com/device/K955472
Methodology: https://510kreport.com/methodology