# K133939: Modified Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet
- Decided: Apr 1, 2014 after 99 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (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). 10 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112345: Distal Volar Radius Plating Systems, Medos International SARL (2011) Summary page 1.
- K050932: Distal Volar Radius Anatomical Plate System, Hand Innovations, Inc. (2005) Summary page 1.
- K060864: Multidirectional Threaded Peg, Hand Innovations, LLC (2006) Summary page 1.

## Most influential descendants
- K161665: VLP Wrist Fracture System (2016), 10 descendants of its own
- K181533: EVOS Wrist Fracture Plating System (2018), 9 descendants of its own
- K210837: Smith & Nephew Plates and Screws (2021), 7 descendants of its own
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), 2 descendants of its own
- K233017: TM Plating System (2023), 1 descendant of its own

## Recalls of this device
- Feb 14, 2022 · Class II · Z-0810-2022: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and
- Jan 29, 2016 · Class II · Z-1082-2016: Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxi

## Indications for use
The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

Source page: https://510kreport.com/device/K133939
Methodology: https://510kreport.com/methodology