# K162635: Distal Radius Plating System

- Pathway: 510(k) (Special)
- Applicant: Miami Device Solutions, LLC
- Decided: Oct 21, 2016 after 30 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: 10 generations back to K962616 (1996). 44 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 47 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.

## Most influential descendants
- K182810: Distal Radius Plating System (2018), 0 descendants of its own
- K172786: MDS Plating System (2017), 0 descendants of its own

## 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/K162635
Methodology: https://510kreport.com/methodology