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Spiralok Anchor

by Depuy Mitek, A Johnson & Johnson Company 2 variants

510(k) K041069

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 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 NumberK041069 Date9 Nov 2004ClearedStatusActive

Recalls

16 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-0146-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0153-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0144-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0147-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0140-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0143-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0141-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0145-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0154-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0148-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0142-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0155-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0150-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0151-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0149-2013 FDA Class II initiated 6 Sep 2012
    • Terminated Z-0152-2013 FDA Class II initiated 6 Sep 2012

    Fracture of SPIRALOK Anchors post op, requiring patient revision

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  • Withdrawn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.

The Spiralok Anchor is a Poly Lactic Acid (PLA) threaded suture anchor designed for bone fixation. It is intended for shoulder rotator cuff repair procedures. The device comes preloaded on a disposable inserter assembly to facilitate secure placement.

The Spiralok Anchor is supplied as a single-use device. It is manufactured by DePuy Mitek, A Johnson & Johnson Company, and has received FDA 510(k) clearance with the product code HWC. The device is not MRI compatible and should be stored according to the manufacturer's instructions.

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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 is the Spiralok Anchor used for?

    The Spiralok Anchor is a Poly Lactic Acid (PLA) threaded suture anchor designed specifically for bone fixation in shoulder rotator cuff repair procedures. It provides secure placement for surgical repairs in the shoulder area.

  • How is the Spiralok Anchor supplied?

    The Spiralok Anchor comes preloaded on a disposable inserter assembly to facilitate secure and easy placement during surgical procedures. Each device is supplied as a single-use item for safety and sterility purposes.

  • Is the Spiralok Anchor reusable or MRI compatible?

    The Spiralok Anchor is supplied as a single-use device and should not be reused. It is not MRI compatible, so patients with this implant should avoid MRI scans as specified by the manufacturer's instructions.

  • What regulatory approvals does the Spiralok Anchor have?

    The Spiralok Anchor has received FDA 510(k) clearance with the product code HWC. It was determined to be substantially equivalent to predicate devices through the traditional clearance process by the Orthopedic review panel.