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DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

by DePuy Synthes

510(k) K163046

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163046↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK163046 Date9 Feb 2017ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate is a locking compression plate designed for internal fixation of distal radius fractures. It features a two-column construct with variable-angle locking screws to provide stable fixation for both intra-articular and extra-articular fractures, osteotomies, nonunions, and malunions, including cases extending into the radial diaphysis. The plate is anatomically contoured to match the distal radius anatomy, ensuring precise alignment and support during bone healing.

This device is supplied in sterile and non-sterile configurations and is intended for use in orthopedic surgical settings. It complies with FDA 510(k) clearance under the Traditional review pathway and meets the requirements of the Medical Device Directive (MDD). The Extra-Long variant is part of the 2.4/2.7mm VA LCP system, offering specific length and screw hole configurations tailored for complex cases. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality.

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