# K012114: Synthes Locking Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 28, 2001 after 84 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
205 later devices descend from it; 16 cite it directly.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate.
- (no number) Synthes Distal Radius Plate System: named in the summary without a submission number

## Most influential descendants
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series (2004), 162 descendants of its own
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates (2010), 80 descendants of its own
- K112455: Aiming Blocks for Variax Distal Radius Plates (2011), 56 descendants of its own
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates (2010), 50 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2389-2016: It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being 
- Nov 2, 2015 · Class II · Z-0323-2016: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above pa
- Dec 5, 2006 · Not classified · Z-0489-2007: Hole is malformed, leading to reduced construct strength.

## Indications for use
The Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Source page: https://510kreport.com/device/K012114
Methodology: https://510kreport.com/methodology