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FlexBand - FlexBand Plus

by International Life Sciences

510(k) K230316

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230316 Date26 May 2023ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1556-2026 FDA Class II initiated 6 Feb 2026
    • Ongoing Z-1554-2026 FDA Class II initiated 6 Feb 2026
    • Ongoing Z-1555-2026 FDA Class II initiated 6 Feb 2026

    Augmentation devices failed bacterial endotoxin testing.

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  • Withdrawn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
OWW
Models / Variants
FlexBand Plus
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 FlexBand; FlexPatch; FlexBand Plus are classified as absorbable orthopaedic surgical meshes designed for tendon reinforcement. These devices are intended to provide temporary support to tendons, including those in the rotator cuff, patellar, Achilles, biceps, medial collateral ligament, lateral collateral ligament, spring ligament, and deltoid ligament, without replacing normal body structure or offering full mechanical strength.

Supplied as single-use devices, the FlexBand; FlexPatch; FlexBand Plus are regulated under FDA 510(k) clearance (K230316) with a classification of Mesh, Surgical, Absorbable, Orthopaedics (Regulation 878.3300). They are intended for use in general and plastic surgery settings, adhering to sterile procedures. The product codes OWW correspond to these devices, which are manufactured by International Life Sciences.

Other devices from International Life Sciences

Questions

AI-generated answers, 18 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 tendons can the FlexBand; FlexPatch; FlexBand Plus be used to reinforce, and how does it differ from a full tendon replacement?

    The FlexBand; FlexPatch; FlexBand Plus are designed to reinforce tendons such as those in the rotator cuff, patellar, Achilles, biceps, medial collateral ligament, lateral collateral ligament, spring ligament, and deltoid ligament. Unlike a full tendon replacement, these devices provide temporary support rather than permanent structural replacement, helping to stabilize the tendon while the body’s natural healing processes take over. They do not offer full mechanical strength but assist in maintaining tendon integrity during recovery.

  • Are the FlexBand; FlexPatch; FlexBand Plus intended for reuse, or are they single-use devices? How should they be handled to maintain sterility?

    The FlexBand; FlexPatch; FlexBand Plus are explicitly supplied as single-use devices, meaning they are not intended for reuse. To ensure sterility, they must be handled using sterile procedures, as they are designed for use in general and plastic surgery settings where maintaining a sterile field is critical. Always follow manufacturer guidelines for opening and handling to prevent contamination.

  • What regulatory pathway was followed for FDA clearance of the FlexBand; FlexPatch; FlexBand Plus, and what does this mean for clinicians?

    The FlexBand; FlexPatch; FlexBand Plus received FDA 510(k) clearance (K230316) under the traditional review pathway, classified as Mesh, Surgical, Absorbable, Orthopaedics (Regulation 878.3300). This clearance indicates the devices were determined to be substantially equivalent to a legally marketed predicate device, meaning they meet the same performance standards and safety expectations. Clinicians can rely on this clearance as evidence of the device’s compliance with FDA requirements for absorbable orthopaedic surgical meshes.

  • What product codes and registration numbers are associated with the FlexBand; FlexPatch; FlexBand Plus, and how might this information be useful?

    The FlexBand; FlexPatch; FlexBand Plus are associated with the product code OWW and multiple registration numbers (e.g., 8043792, 1721676, etc.), which correspond to specific lots or variants. This information can be useful for inventory management, tracking recalls, or verifying device authenticity. The registration numbers also align with the OpenFDA database, allowing clinicians or administrators to access detailed records about the device’s manufacturing history and compliance status.

  • How are the FlexBand; FlexPatch; FlexBand Plus manufactured, and what does their absorbable nature imply for patients?

    The FlexBand; FlexPatch; FlexBand Plus are absorbable orthopaedic surgical meshes, meaning they are designed to gradually break down and be absorbed by the body over time. This eliminates the need for a secondary surgical procedure to remove the device, as the material dissolves as the tendon heals. However, patients should be informed that while the mesh absorbs, the tendon reinforcement process relies on the body’s natural healing, so compliance with postoperative rehabilitation is essential for optimal outcomes.