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FlexFusion Fixation Implant

by Nextremity Solutions, LLC

510(k) K110445

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 NumberK110445 Date17 Mar 2011ClearedStatusActive

Recalls

6 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0913-2022 FDA Class II initiated 10 Feb 2022
    • Terminated Z-0912-2022 FDA Class II initiated 10 Feb 2022
    • Terminated Z-0910-2022 FDA Class II initiated 10 Feb 2022
    • Terminated Z-0911-2022 FDA Class II initiated 10 Feb 2022
    • Terminated Z-0914-2022 FDA Class II initiated 10 Feb 2022

    Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

    • Terminated Z-1458-2020 FDA Class II initiated 12 Feb 2020

    Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Flexfusion (Tm) Fixation Implant
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, 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 FlexFusion Fixation Implant is a two-part orthopedic device classified as a bone fixation implant. It is designed for small bone reconstruction, specifically for inter-digital repair and fusion of the lesser toes, providing rigid stabilization during the healing process. Constructed as a 3.4mm diameter system, it consists of proximal and distal components intended to be used together.

Supplied as a procedure pack, the device includes surgical site preparation tools and insertion instruments. It is intended for single-use and is regulated under FDA 510(k) clearance (K110445) with a traditional review pathway. The implant is not labeled as MRI-safe or sterile upon packaging, and storage conditions should follow manufacturer guidelines to maintain integrity. Authorized for use in orthopedic procedures, it adheres to FDA-substantiated equivalence standards for orthopedic fixation devices.

Other devices from Nextremity Solutions, Inc.

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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 is the FlexFusion Fixation Implant used for?

    The FlexFusion Fixation Implant is specifically designed for small bone reconstruction, particularly for inter-digital repair and fusion of the lesser toes. It offers rigid stabilization during the healing process to ensure proper alignment and recovery of the affected toes.

  • How is the FlexFusion Fixation Implant supplied?

    The device is supplied as a complete procedure pack, which includes the proximal and distal components of the implant as well as surgical site preparation tools and insertion instruments. This ensures all necessary components are available for a single surgical procedure.

  • Is the FlexFusion Fixation Implant single-use or reusable?

    The FlexFusion Fixation Implant is intended for single-use only. This design choice helps maintain sterility and reduce the risk of cross-contamination between patients, adhering to best practices in orthopedic surgery.

  • What are the key specifications of the FlexFusion Fixation Implant?

    The implant features a 3.4mm diameter system consisting of two components: a proximal and a distal part. These components are designed to work together to provide stable fixation during toe fusion procedures, ensuring optimal healing conditions.

  • What storage conditions should be followed for the FlexFusion Fixation Implant?

    While the implant is not sterile upon packaging, it must be stored according to the manufacturer’s guidelines to maintain its integrity and functionality. Proper storage conditions help preserve the device’s performance and ensure it remains suitable for use in surgical procedures.