# K112345: Distal Volar Radius Plating Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Oct 31, 2011 after 77 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K133939: Modified Distal Radius Plating System (2014), 11 descendants of its own
- 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

## Recalls of this device
- Nov 20, 2018 · Class II · Z-0708-2019: One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm 
- Nov 20, 2018 · Class II · Z-0709-2019: One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm 
- 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
- Mar 18, 2015 · Class II · Z-1446-2015: A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.

Source page: https://510kreport.com/device/K112345
Methodology: https://510kreport.com/methodology