# K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 9, 2010 after 80 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
Longest line of descent: 2 generations back to K962616 (1996). 6 ancestors in all.
50 later devices descend from it; 13 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 1.
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 1.
- K023879: Small Titanium Wrist Fusion Plate, Synthes (Usa) (2003) Summary page 1.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 1.

## Most influential descendants
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 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
- Jan 11, 2013 · Class II · Z-0956-2013: It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).

## Indications for use
The 2.4 mm Variable Angle LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The 2.4 mm LCP Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The 2.4mm Variable Angle LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The Variable Angle LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. 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 in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The Ti-15Mo Locking Distal Radius Plating System Distal System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.

Source page: https://510kreport.com/device/K102694
Methodology: https://510kreport.com/methodology