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Modification to Synthes (USA) Titanium Wire

by Synthes (Usa) 510(k)

Active United States

510(k) K042606

Overview

The Modification to Synthes (USA) Titanium Wire is a nonabsorbable suture made of steel, available in monofilament and multifilament forms, and is sterile. It is intended for use in general and plastic surgery procedures.

This device is supplied sterile and is classified as a Class II medical device. It is authorized under FDA 510K clearance with K number K042606 and product code GAQ. The device is manufactured by Synthes (USA) and is available in various sizes as specified in the registration numbers.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042606 Date27 May 2005ClearedStatusActive

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
GAQ
Device Class
Class II
Regulation
21 CFR Part 878.4495
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Synthes (Usa)

See all devices from Synthes (Usa) →

Questions

  • What is the Modification to Synthes (USA) Titanium Wire used for?

    This device is a nonabsorbable suture made of steel, intended for use in general and plastic surgery procedures. It is available in both monofilament and multifilament forms to accommodate different surgical needs.

  • Is the Modification to Synthes (USA) Titanium Wire supplied sterile?

    Yes, the Modification to Synthes (USA) Titanium Wire is supplied sterile, ensuring it meets the necessary hygiene requirements for surgical procedures without the need for additional sterilization by the user.

  • What sizes and models are available for the Modification to Synthes (USA) Titanium Wire?

    The device is available in various sizes as specified in the registration numbers provided. Each size is designed to meet specific surgical requirements, though the exact dimensions should be referenced in the product documentation for precise information.

  • What is the regulatory status of the Modification to Synthes (USA) Titanium Wire?

    This device is classified as a Class II medical device and is authorized under FDA 510K clearance with K number K042606 and product code GAQ. It has been determined to be substantially equivalent to predicate devices.