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FuseForce Flex Dynamic Compression System

by Wright Medical 510(k)

Active United States

510(k) K203832

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203832 Date7 May 2021ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0853-2022 FDA Class II initiated 10 Mar 2022

    The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

Specification

510(k)

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

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FuseForce Flex Dynamic Compression System is a device used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle. It provides dynamic compression using nitinol staples. The system is designed to be used with corresponding single-use sterile surgical instruments.

The FuseForce Flex Dynamic Compression System is supplied in nine unique sizes, ranging from 8 to 25mm. It is a single-use, sterile device and has received FDA 510(k) clearance. The system is intended for use in orthopedic procedures and is manufactured by Wright Medical.

Other devices from Wright Medical

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FuseForce Flex Dynamic Compression System used for?

    The FuseForce Flex Dynamic Compression System is used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle, providing dynamic compression using nitinol staples.

  • Is the FuseForce Flex Dynamic Compression System sterile and single-use?

    Yes, the FuseForce Flex Dynamic Compression System is a single-use, sterile device, supplied with corresponding single-use sterile surgical instruments.

  • What sizes is the FuseForce Flex Dynamic Compression System available in?

    The FuseForce Flex Dynamic Compression System is supplied in nine unique sizes, ranging from 8 to 25mm.