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TwinFix Ultra Ti Suture Anchor

by Smith & Nephew Inc., Endoscopy Div.

510(k) K100159

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK100159 Date19 Apr 2010ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2167-2012 FDA Class II initiated 3 Jul 2012
    • Terminated Z-2165-2012 FDA Class II initiated 3 Jul 2012
    • Terminated Z-2166-2012 FDA Class II initiated 3 Jul 2012
    • Terminated Z-2168-2012 FDA Class II initiated 3 Jul 2012

    Distal part of the anchor may break on insertion into bone during surgery

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Smith and Nephew Twinfix Ultra Ti Suture Anchor
510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 TwinFix Ultra Ti Suture Anchor is a soft tissue fixation device classified as a suture anchor (product code MBI) under the Orthopedic category. It is designed to secure soft tissue to bone, facilitating surgical repairs such as rotator cuff reattachment in the shoulder.

This device is supplied preloaded with needles and sutures, intended for single-use applications in orthopedic procedures. It has received FDA 510(k) clearance under the Traditional pathway and is intended for use in mini-open rotator cuff repairs. The device is not described as MRI-safe or reusable, and no sterility or storage specifications are provided in the data.

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Questions

AI-generated answers, 19 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 types of surgical procedures is the TwinFix Ultra Ti Suture Anchor specifically designed for?

    The TwinFix Ultra Ti Suture Anchor is specifically designed for securing soft tissue to bone during orthopedic procedures, with FDA clearance for use in mini-open rotator cuff repairs of the shoulder. Its purpose is to facilitate surgical repairs where stable fixation is required, such as reattaching the rotator cuff.

  • Is the TwinFix Ultra Ti Suture Anchor intended for reuse, or is it meant to be used only once?

    The TwinFix Ultra Ti Suture Anchor is explicitly intended for single-use applications. It is supplied preloaded with needles and sutures, which are not designed to withstand repeated sterilization or reuse, ensuring patient safety and device efficacy.

  • How is the TwinFix Ultra Ti Suture Anchor supplied, and what components come preloaded?

    The TwinFix Ultra Ti Suture Anchor is supplied preloaded with both needles and sutures, ready for immediate use in surgical procedures. This preloaded configuration simplifies the surgical workflow by eliminating the need for separate attachment steps.

  • What regulatory pathway was followed for FDA clearance of the TwinFix Ultra Ti Suture Anchor?

    The TwinFix Ultra Ti Suture Anchor received FDA clearance through the Traditional 510(k) pathway, which involves demonstrating substantial equivalence to a legally marketed predicate device. The clearance was granted under the Orthopedic category, specifically for product code MBI (suture anchors).