# K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 6, 2009 after 84 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
No predicates in its family tree.
29 later devices descend from it; 12 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes LCP Volar Distal Radius Plates: named in the summary without a submission number

## Most influential descendants
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K160002: Piccolo Composite (R) Distal Volar Radius Plate System (2016), 4 descendants of its own
- K170401: Piccolo Composite® Plate System (2017), 3 descendants of its own
- K093761: Optilock VL (Variable Angle Locking) Distal Radius Plating System (2010), 3 descendants of its own

## Recalls of this device
- Jul 30, 2013 · Class II · Z-2087-2013: The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
- May 31, 2013 · Class II · Z-2057-2013: The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA

## Indications for use
The Synthes 2.4 mm VA-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.

Source page: https://510kreport.com/device/K083694
Methodology: https://510kreport.com/methodology