Skip to content

Darco Headed Cannulated Screw

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K100359

Overview

The Darco Headed Cannulated Screw is an orthopedic fixation device classified as a cannulated screw (Device Type: HWC). It is designed for internal fixation of bone fractures in the forefoot, midfoot, and hindfoot regions, providing stable compression to promote proper healing. The screw features a threaded, cannulated shaft with a reverse cutting flute to facilitate easy insertion and removal. Available in multiple diameters, it is intended for use in procedures requiring precise bone alignment and stabilization.

This device is supplied as a reusable surgical instrument and is intended for single-use per patient procedure. The screw diameters range from 2.7mm to 7.5mm, with a separate 7.0mm headless option available. It is self-drilling and self-tapping, reducing operative time and improving handling. The Darco Headed Cannulated Screw holds FDA 510(k) clearance (K100359) under the Orthopedic (OR) advisory committee and is regulated as a Class II medical device under the Traditional 510(k) pathway.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100359 Date24 Jun 2010ClearedStatusActive

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

Other devices from Wrightmedicaltechnologyinc

See all devices from Wrightmedicaltechnologyinc →

Questions

  • What is the Darco Headed Cannulated Screw used for?

    This device is designed for internal fixation of bone fractures in the forefoot, midfoot, and hindfoot regions. Its threaded, cannulated shaft with reverse cutting flutes provides stable compression to support proper bone healing during surgical procedures requiring precise alignment and stabilization.

  • How is the Darco Headed Cannulated Screw supplied and intended for use?

    The screw is supplied as a reusable surgical instrument but is intended for single-use per patient procedure. This ensures sterility and reduces cross-contamination risks, aligning with best practices for orthopedic fixation devices.

  • What sizes and variations are available for the Darco Headed Cannulated Screw?

    The screw comes in diameters ranging from 2.7mm to 7.5mm, with a separate 7.0mm headless option available. The self-drilling and self-tapping design simplifies insertion, making it versatile for various foot fracture cases requiring different fixation strengths.

  • Is the Darco Headed Cannulated Screw sterile upon receipt?

    The device is not pre-sterilized in its supplied packaging. It must be sterilized by the facility prior to use, adhering to standard surgical instrument protocols. This ensures compliance with infection control standards for orthopedic procedures.

  • What regulatory pathway does the Darco Headed Cannulated Screw follow?

    The device holds FDA 510(k) clearance (K100359) under the Orthopedic (OR) advisory committee, classified as a Class II medical device. It was determined substantially equivalent to a predicate device through the Traditional 510(k) pathway, meeting U.S. regulatory requirements for orthopedic fixation hardware.