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Synthes Self-Drilling Schanz Screw

by Synthes (Usa)

510(k) K952296

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 NumberK952296 Date18 Aug 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0043-2018 FDA Class II initiated 18 Sep 2017

    The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Synthes (USA) [Synthes[ Self-Drilling Schanz Screw
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, 1 Oct 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 Self-Drilling Schanz Screw is a self-drilling orthopedic fixation device designed for securing external fixation frames to bone. It is classified as an orthopedic screw under the FDA’s product code HWC, intended for use in stabilizing long bones during external fixation procedures. The screw’s self-drilling feature eliminates the need for separate drilling, streamlining the application process. Its design ensures secure anchorage within cortical bone, reducing the risk of loosening or displacement.

This device is supplied as a single-use, sterile item and is regulated under FDA 510(k) clearance (K952296) as substantially equivalent to existing orthopedic fixation products. Available in a 5.0mm diameter with a 60mm threaded section and an overall length of 175mm (as referenced in specifications), it is intended for use in orthopedic settings where precise bone fixation is required. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.

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