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Synthes (USA) 3.5MM Conical Screws

by Synthes (Usa)

510(k) K050683

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050683 Date27 Apr 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1800-2015 FDA Class II initiated 13 May 2015

    Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 24 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 Synthes (USA) 3.5mm Conical Screws are orthopedic bone fixation fasteners designed for use with existing Synthes LCP plating systems. These screws feature self-tapping threads and are available with stardrive or hex drive recesses. They are manufactured from stainless steel or titanium and come in lengths ranging from 40-95 mm.

The screws are used by surgeons in clinical settings for bone fracture fixation and interfragmentary compression. They are supplied as single-use devices and require appropriate storage conditions. The device received FDA 510(k) clearance on April 27, 2005, with product code HWC and is classified as Class II - Special Controls.

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See all devices from Synthes (Usa) →

Questions

AI-generated answers, 24 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 are the Synthes 3.5mm Conical Screws used for?

    These orthopedic bone fixation fasteners are designed for use with existing Synthes LCP plating systems to provide bone fracture fixation and interfragmentary compression in clinical settings.

  • What materials are the Synthes 3.5mm Conical Screws available in?

    The screws are manufactured from either stainless steel or titanium and come in various lengths ranging from 40-95mm to accommodate different clinical requirements.

  • Are the Synthes 3.5mm Conical Screws single-use or reusable devices?

    These screws are supplied as single-use devices, meaning they should be used for one patient procedure only and not reused or resterilized for subsequent use.

  • What drive options are available for the Synthes 3.5mm Conical Screws?

    The screws feature either stardrive or hex drive recesses, providing surgeons with different options for insertion depending on their preference and clinical requirements.