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Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa

by Smith & Nephew, Inc.

510(k) K151105

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

40 ongoing

This device is named in the recall

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 NumberK151105 Date28 Jul 2015ClearedStatusActive

Recalls

40 recalls · 40 ongoing · FDA

  • 40 recalls, same reason

    • Ongoing Z-0159-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0161-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0148-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0139-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0141-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0169-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0146-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0170-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0155-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0174-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0149-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0168-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0147-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0172-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0136-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0143-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0137-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0154-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0165-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0175-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0163-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0151-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0162-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0153-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0145-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0167-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0157-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0138-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0150-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0142-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0140-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0152-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0166-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0158-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0144-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0173-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0160-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0156-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0164-2021 FDA Class II initiated 9 Sep 2020
    • Ongoing Z-0171-2021 FDA Class II initiated 9 Sep 2020

    Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

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, 1 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 Smith and Nephew Suture Anchors are orthopedic devices designed for soft tissue fixation to bone. These anchors are used to secure tendons, ligaments, or other soft tissues during surgical procedures, providing stable attachment and promoting tissue integration. The product line includes absorbable and non-absorbable options, each tailored for specific anatomical applications, such as tendon reattachment or meniscal repair. Their construction ensures minimal tissue trauma while maintaining durability under physiological loads.

These suture anchors are supplied sterile and intended for single-use in orthopedic surgeries. They are available in various sizes and configurations, including straight and curved variants, to accommodate different anatomical sites and surgical techniques. The devices are classified under the FDA’s orthopedic category and have received Traditional 510(k) clearance, ensuring compliance with regulatory standards for safety and performance. Proper storage requires adherence to manufacturer guidelines to maintain sterility and functionality prior to use.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Questions

AI-generated answers, 1 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 are Smith & Nephew Suture Anchors used for in orthopedic surgery?

    Smith & Nephew Suture Anchors are designed to securely attach soft tissues—such as tendons or ligaments—to bone during surgical procedures. They provide stable fixation while minimizing tissue trauma, making them ideal for applications like tendon reattachment, meniscal repair, and other soft tissue-to-bone repairs. The anchors are engineered to promote tissue integration and withstand physiological loads, ensuring reliable healing outcomes.

  • Are these suture anchors absorbable, and if so, which models are?

    Yes, Smith & Nephew offers both absorbable and non-absorbable suture anchors. The 5.0mm Absorbable Polymer Anchor is designed to degrade over time, while other models like the TAG Bioraptor, Osteoraptor, Twinfix Ultra HA, and Ultra Fast-Fix Meniscal Repair System are non-absorbable. The absorbable option eliminates the need for removal, whereas non-absorbable anchors provide long-term fixation where durability is critical.

  • How are these suture anchors supplied, and are they sterile?

    Smith & Nephew Suture Anchors are supplied sterile and single-use only, adhering to strict manufacturing standards to ensure safety and reliability in surgical settings. Each package is individually sealed to maintain sterility until use, and they are not intended for reuse or reprocessing. Always follow the manufacturer’s storage instructions to preserve sterility and functionality.

  • What sizes and configurations are available, and how do I choose the right one?

    The Smith & Nephew Suture Anchor line includes multiple sizes and configurations to suit different anatomical sites and surgical needs. Key options include the 5.0mm Absorbable Polymer Anchor, 2.3mm Bioraptor PK, Osteoraptor (straight and curved), and Twinfix Ultra HA. The Ultra Fast-Fix Meniscal Repair System is tailored for meniscal repairs. Selection depends on factors like tissue type, bone density, and surgical technique—consult product documentation or a surgical guide for precise matching.

  • How should these suture anchors be stored to maintain their integrity?

    To ensure sterility and functionality, store Smith & Nephew Suture Anchors in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise sterility. Always check expiration dates and follow the manufacturer’s storage guidelines to prevent degradation before use.