# K132704: Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow

- Pathway: 510(k) (Traditional)
- Applicant: Biomet
- Decided: Oct 9, 2013 after 41 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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: 1 generation back to K112345 (2011). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K191118: Avanti Distal Radius and Forearm System (2019), 1 descendant of its own
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own

## Recalls of this device
- 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 dlistal radius.

Source page: https://510kreport.com/device/K132704
Methodology: https://510kreport.com/methodology