Skip to content

Reduce Fracture Plating System Line Extension

by Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic

510(k) K142135

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

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

Overview

A comprehensive and detailed explanation of our service, written in natural language for clear understanding.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK142135 Date28 Aug 2014ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2117-2018 FDA Class II initiated 6 Apr 2018
    • Terminated Z-2128-2018 FDA Class II initiated 6 Apr 2018
    • Terminated Z-2118-2018 FDA Class II initiated 6 Apr 2018
    • Terminated Z-2116-2018 FDA Class II initiated 6 Apr 2018
    • Terminated Z-2125-2018 FDA Class II initiated 6 Apr 2018

    Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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

Other devices from Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic