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Ortholoc 3Di Foot Plating Reconstruction System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K152974

Overview

The Ortholoc 3Di Foot Plating Reconstruction System is a multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot. Each implant has been designed with a focus on strength, versatility, and low-profile anatomic contours.

The system focuses on implant solutions related to joint arthrodesis and stabilizations of the foot, providing highly anatomic and versatile plating options for an array of fusions and stabilizations. The device is authorized under FDA 510K clearance with product code HRS and was received on 2015-10-08 with a decision date of 2015-12-11.

AI-generated from registry data, 27 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 NumberK152974 Date11 Dec 2015ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Ortholoc 3Di Foot Plating Reconstruction System used for?

    The Ortholoc 3Di Foot Plating Reconstruction System is designed for joint arthrodesis and stabilization procedures in the forefoot and midfoot. It provides anatomic and versatile plating options for various fusion and stabilization procedures.

  • How is the Ortholoc 3Di Foot Plating Reconstruction System supplied?

    The system is supplied with indication-specific implants and instruments designed to address the unique demands of foot reconstruction procedures. Each implant is designed with a focus on strength, versatility, and low-profile anatomic contours.

  • What is the regulatory status of the Ortholoc 3Di Foot Plating Reconstruction System?

    The device is authorized under FDA 510K clearance with product code HRS. It was received on October 8, 2015, with a decision date of December 11, 2015, and was determined to be substantially equivalent.

  • What are the key design features of the Ortholoc 3Di implants?

    The implants are designed with a focus on strength, versatility, and low-profile anatomic contours. They are specifically engineered to meet the unique demands of foot reconstruction procedures, particularly for arthrodesis and stabilization.