# K141493: Proximal Humerus Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Miami Device Solutions
- Decided: Mar 20, 2015 after 288 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 39 ancestors in all.
7 later devices descend from it; 3 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)
- K041965: Arthrex Humeral Fracture Plates and Screws, Arthrex, Inc. (2004) Summary page 4.
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 4.
- K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V, Zimmer GmbH (2008) Summary page 4.

## Most influential descendants
- K161292: Distal Radius Plating System (2016), 4 descendants of its own
- K162635: Distal Radius Plating System (2016), 2 descendants of its own
- K162898: Olecranon Plating System (2017), 1 descendant of its own
- K161058: Cannulated Screw (2016), 1 descendant of its own
- K182810: Distal Radius Plating System (2018), 0 descendants of its own

## Recalls of this device
- Jan 15, 2019 · Class II · Z-0603-2020: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

## Indications for use
The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.

Source page: https://510kreport.com/device/K141493
Methodology: https://510kreport.com/methodology