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Microsuture Anchors

by Arthrex, Inc.

510(k) K112237

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 NumberK112237 Date2 Sep 2011ClearedStatusActive

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  • Withdrawn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
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Microsuture Anchors are bone fixation screws designed for the repair of soft tissue to bone. They are intended for use in suture or tissue fixation procedures involving the foot, ankle, knee, hand, wrist, elbow, and shoulder.

This device is supplied by Arthrex, Inc. and has received FDA 510(k) clearance under K112237. It is classified as a Class II medical device under product code HWC.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 27 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 Microsuture Anchors used for?

    These devices are bone fixation screws specifically designed to facilitate the repair of soft tissue to bone. They are indicated for use in surgical procedures involving the foot, ankle, knee, hand, wrist, elbow, and shoulder.

  • What is the regulatory status of the Microsuture Anchors?

    The Microsuture Anchors have received FDA 510(k) clearance under K112237. The device is classified as a Class II medical device under product code HWC, which pertains to orthopedic bone fixation hardware.

  • Who is the manufacturer of this device?

    The Microsuture Anchors are manufactured by Arthrex, Inc., located in Naples, Florida. The device was submitted for regulatory review by this company and received clearance in September 2011.