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Charlotte 7.0 Multi-Use Compression Screw and Washer

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K070525

Overview

The Charlotte 7.0 Multi-Use Compression Screw and Washer is a metallic bone fixation device. This cannulated, headless screw features a double-lead helical thread pattern and is designed for use in osteotomies and fusions of the forefoot, midfoot, and hindfoot.

The system includes screws of varying lengths and thread patterns paired with washers for straight or oblique placement. This device is classified as a Class II bone fixation screw under product code HWC and has received FDA 510(k) clearance.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070525 Date29 Mar 2007ClearedStatusActive

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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical application for the Charlotte 7.0 system?

    This device is designed for bone fixation during osteotomies and fusions. It is specifically indicated for procedures involving the forefoot, midfoot, and hindfoot, utilizing a double-lead helical thread pattern to provide compression.

  • What are the design features of the Charlotte 7.0 screw?

    The Charlotte 7.0 is a cannulated, headless metallic screw. It features a double-lead helical thread pattern and is supplied with washers to accommodate both straight and oblique placement during surgical procedures.

  • What is the regulatory status of this fixation device?

    The Charlotte 7.0 Multi-Use Compression Screw and Washer is classified as a Class II bone fixation screw under product code HWC and has received FDA 510(k) clearance under K070525.