# K161292: Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Miami Device Solutions, LLC
- Decided: Aug 15, 2016 after 98 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: 9 generations back to K962616 (1996). 43 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 4.
- K141430: Variax Distal Radius Plating System, Stryker Leibinger GmbH & Co KG (2014) Summary page 4.
- K141493: Proximal Humerus Plating System, Miami Device Solutions (2015) Summary page 4.

## Most influential descendants
- K162635: Distal Radius Plating System (2016), 2 descendants of its own
- K162898: Olecranon Plating System (2017), 1 descendant of its own
- 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/K161292
Methodology: https://510kreport.com/methodology