# K133246: Zimmer Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 17, 2013 after 56 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: 3 generations back to K885250 (1989). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 1.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 1.

## Most influential descendants
- K182810: Distal Radius Plating System (2018), 0 descendants of its own
- K171624: IXOS Radius Plate System (2018), 0 descendants of its own

## Indications for use
The Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures, fractures in osteopenic bone, non-unions, and mal-unions.

Source page: https://510kreport.com/device/K133246
Methodology: https://510kreport.com/methodology