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Freefix Forearm Plating System

by Skeletal Dynamics, Inc. 510(k)

Active United States

510(k) K242055

Overview

The Freefix Forearm Plating System is a set of bone plates designed for the repair of midshaft radius and ulna fractures. The system features locking plate technology that allows the fracture to dictate screw placement, with the head of the eccentrically placed screw engaging the plate.

The system includes titanium bone screws, k-wires, and specialized instrumentation, with plates available in various sizes made of medical grade titanium alloy. This device is authorized under FDA 510k clearance K242055.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK242055 Date1 Aug 2024ClearedStatusActive

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 intended use of the Freefix Forearm Plating System?

    The Freefix Forearm Plating System is indicated for the repair of midshaft radius and ulna fractures. It utilizes locking plate technology to stabilize bone segments during the healing process.

  • What components are included in the Freefix Forearm Plating System?

    The system is composed of medical grade titanium alloy plates and includes titanium bone screws, k-wires, and specialized instrumentation required for the surgical procedure.

  • How does the locking plate technology function in this system?

    The system features locking plate technology that allows the fracture site to dictate the placement of screws, with the head of the eccentrically placed screw engaging directly with the plate for secure fixation.

  • What is the regulatory status of this device?

    The Freefix Forearm Plating System is authorized under FDA 510k clearance K242055, which was granted on August 1, 2024.