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Arthrex Suture (UHMWPE)

by Arthrex, Inc.

510(k) K122374

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Special NumberK122374 Date25 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GAT
Device class
Class II
Regulation
21 CFR Part 878.5000
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Arthrex Suture (UHMWPE) is a braided surgical suture construct composed of ultra-high molecular weight polyethylene (UHMWPE). It is designed for use in orthopedic surgery, offering superior strength, soft feel, and abrasion resistance.

The suture is supplied as a sterile, single-use device. It is intended for use by trained healthcare professionals and is regulated under FDA 510(k) clearance. Proper storage and handling are required to maintain sterility and functionality.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Arthrex UHMWPE Suture used for?

    This braided suture is designed for use in orthopedic surgery to provide superior strength, a soft feel, and abrasion resistance.

  • Is the Arthrex UHMWPE Suture sterile?

    Yes, the suture is supplied as a sterile, single-use device intended for use by trained healthcare professionals.

  • How should the Arthrex UHMWPE Suture be stored?

    Proper storage and handling are required to maintain sterility and functionality, as specified by the manufacturer.

  • Is the Arthrex UHMWPE Suture intended for single use?

    Yes, the device is intended for single use and should not be reused to ensure patient safety and device integrity.