# K182810: Distal Radius Plating System

- Pathway: 510(k) (Special)
- Applicant: Miami Device Solutions, LLC
- Decided: Dec 10, 2018 after 68 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: 11 generations back to K962616 (1996). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161292: Distal Radius Plating System, Miami Device Solutions, LLC (2016) Summary page 4.
- K162635: Distal Radius Plating System, Miami Device Solutions, LLC (2016) Summary page 4.
- K071092: Asnis Micro Cannulated Screw, Howmedica Osteonics Corp. (2007) Summary page 4.
- K133246: Zimmer Distal Radius Plating System, Zimmer, Inc. (2013) Summary page 4.

## Indications for use
The MDS Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.

Source page: https://510kreport.com/device/K182810
Methodology: https://510kreport.com/methodology