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Healix Advance Knotless Br Anchor (6.5MM)

by Depuy Mitek, A Johnson & Johnson Company

510(k) K131974

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 NumberK131974 Date25 Jul 2013ClearedStatusActive

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  • Withdrawn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
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
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.

The Healix Advance Knotless Br Anchor is a one-piece, cannulated, threaded implant designed to secure soft tissue to bone. It is provided pre-loaded on a disposable inserter driver. The device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue device.

The Healix Advance Knotless Br Anchor is supplied in a size of 6.5mm and is intended for use in orthopedic applications, such as rotator cuff repairs and biceps tenodesis. The device has been cleared by the FDA under the 510(k) clearance type, with a regulation number of 888.3030 and a product code of MAI.

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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 Healix Advance Knotless Br Anchor used for?

    The Healix Advance Knotless Br Anchor is used for orthopedic applications, such as rotator cuff repairs and biceps tenodesis.

  • How is the Healix Advance Knotless Br Anchor supplied?

    The device is supplied pre-loaded on a disposable inserter driver in a size of 6.5mm.

  • Is the Healix Advance Knotless Br Anchor sterile?

    The description does not explicitly state the sterility of the device, but it is intended for use in orthopedic applications where sterility is typically required.

  • Is the Healix Advance Knotless Br Anchor single-use or reusable?

    The device is supplied with a disposable inserter driver, suggesting it is intended for single-use.