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Synthes Variable Angle LCP Elbow System

by Synthes (Usa) 510(k)

Active United States

510(k) K120070

Overview

The Synthes Variable Angle LCP Elbow System is a locking plate and screw construct designed for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents whose growth plates have fused. It incorporates variable‑angle locking technology that allows the surgeon to adjust screw trajectories while maintaining stable fixation.

The system was cleared through a traditional FDA 510(k) submission (K120070, product code HRS) and is marketed by Synthes USA. It is supplied as a set of plates and instrumentation in 2.7 mm and 3.5 mm sizes and is intended for use in orthopedic surgical settings.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120070 Date21 Mar 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0124-2016 FDA Class II initiated 28 Sep 2015

    The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S

Specification

510(k)

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

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