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Osteowedge Opening Wedge Bone Locking System

by Graham Medical Technologies, LLC 510(k)

Active United States

510(k) K111326

Overview

The Osteowedge Opening Wedge Bone Locking System is a metallic bone fixation system consisting of locking plates and screws. It is designed for stabilization and correction of angular deviations in foot bones, such as the first metatarsal cuneiform joint, utilizing a screw-to-plate locking mechanism to secure the plate to prepared bone surfaces.

The system is available in six wedge sizes with two screw diameters and is intended for use by healthcare professionals in foot and ankle surgery. It is supplied as a non-sterile, reusable device and requires sterilization prior to use. The device received FDA 510(k) clearance (K111326) and is classified under product code HRS with orthopedic advisory committee review.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111326 Date6 Jul 2011ClearedStatusActive

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

From the manufacturer

Osteo-Wedge® Open Wedge Bone Locking System. Designed to provide stable, reliable fixation for bone wedge procedures in foot and ankle surgery.

Source: gramedica.com

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Questions

  • What is the Osteowedge Opening Wedge Bone Locking System used for?

    The Osteowedge Opening Wedge Bone Locking System is designed for stabilization and correction of angular deviations in foot bones, such as the first metatarsal cuneiform joint, utilizing a screw-to-plate locking mechanism to secure the plate to prepared bone surfaces during foot and ankle surgery.

  • How is the Osteowedge Opening Wedge Bone Locking System supplied and prepared for use?

    The system is supplied as a non-sterile, reusable device and requires sterilization prior to use by healthcare professionals in foot and ankle surgery.

  • What sizes and configurations are available for the Osteowedge Opening Wedge Bone Locking System?

    The system is available in six wedge sizes with two screw diameters, allowing for selection based on the specific anatomical needs and surgical requirements in foot and ankle procedures.