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Arthrex SwiveLock Anchors

by Arthrex, Inc. 6 variants

510(k) K180768

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 · Traditional NumberK180768 Date14 Dec 2018ClearedStatusActive

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  • Withdrawn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, 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.

Arthrex SwiveLock Anchors are fixation devices used for soft-tissue repair and soft tissue-to-bone reattachment. These anchors are made from an inert, radiolucent, and non-absorbable thermosplastic material called PEEK. The 4.75 mm DX Knotless SwiveLock anchors provide surgeons with the added benefit of a knotless repair retention suture feature.

The SwiveLock anchors are available in various sizes and are used for repairs including CCLs and ligament augmentation repair technology. They are supplied with a free needle and accommodate SutureTape and other biologic materials. The device is FDA 510(k) cleared with product code MAI and is classified as a Class II device.

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 Arthrex SwiveLock Anchors used for?

    Arthrex SwiveLock Anchors are fixation devices designed for soft-tissue repair and soft tissue-to-bone reattachment. They are commonly used for repairs including CCLs and ligament augmentation repair technology.

  • What materials are Arthrex SwiveLock Anchors made from?

    These anchors are made from an inert, radiolucent, and non-absorbable thermosplastic material called PEEK. The 4.75 mm DX Knotless SwiveLock anchors provide surgeons with the added benefit of a knotless repair retention suture feature.

  • What sizes and models of SwiveLock Anchors are available?

    The SwiveLock anchors are available in various sizes to accommodate different surgical needs. They are supplied with a free needle and can accommodate SutureTape and other biologic materials for versatile surgical applications.

  • What is the regulatory status of Arthrex SwiveLock Anchors?

    The device is FDA 510(k) cleared with product code MAI and is classified as a Class II device. This means it has been determined to be substantially equivalent to other legally marketed devices of the same type.