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MENIX® - Menix® Duo

by S.B.M. Sas (Science & Bio Materials)

510(k) K223122

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223122↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK223122 Date3 Aug 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GAT
Models / Variants
Menix® Duo
Device Class
Class II
Regulation
21 CFR Part 878.5000
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Menix Duo is an all-inside meniscal repair system classified as a meniscal suture device. It is designed for repairing meniscal tears through minimally invasive techniques, preserving native meniscal tissue to reduce the risk of osteoarthritis. The system employs two PEEK anchors connected by a UHMWPE suture, providing secure fixation within the meniscus.

The Menix Duo is supplied as a single-use device, consisting of a dedicated launcher for implant deployment. It is intended for use in orthopedic surgical settings and has received FDA 510(k) clearance under the General, Plastic Surgery advisory committee (SU). The device is regulated under product code GAT and is authorized for marketing in the European Union under MDR compliance. Storage and handling follow standard sterile surgical instrument protocols.

Other devices from S.B.M. Sas (Science & Bio Materials)

Questions

AI-generated answers, 20 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 meniscal tears is the Menix Duo system designed to address and how does it work?

    The Menix Duo is specifically designed for repairing meniscal tears using an all-inside technique, which preserves the native meniscus tissue. It employs two PEEK anchors connected by a UHMWPE suture to provide secure fixation within the meniscus, helping to reduce the risk of osteoarthritis by maintaining tissue integrity. This system is intended for minimally invasive surgical procedures in orthopedic settings.

  • Is the Menix Duo system reusable or single-use, and how is it supplied?

    The Menix Duo is a single-use device, meaning it is intended for one-time use only. It comes as a complete system, including a dedicated launcher for implant deployment, ensuring sterility and ease of use in surgical settings.

  • What regulatory pathways has the Menix Duo system undergone, and where is it authorized for use?

    The Menix Duo has received FDA 510(k) clearance under the General, Plastic Surgery advisory committee (SU) and is classified under product code GAT. It is also authorized for marketing in the European Union under MDR compliance, adhering to strict regulatory standards for medical devices.

  • How should the Menix Duo system be stored and handled to maintain its integrity?

    The Menix Duo follows standard sterile surgical instrument protocols for storage and handling. This ensures the device remains uncontaminated and ready for use in orthopedic surgical environments, maintaining its performance and safety.

  • What materials are used in the Menix Duo system, and how do they contribute to its function?

    The Menix Duo system utilizes PEEK (polyether ether ketone) anchors for secure fixation and UHMWPE (ultra-high-molecular-weight polyethylene) suture to connect the anchors. These materials provide durability, biocompatibility, and stability within the meniscus, enabling effective repair of meniscal tears while minimizing the risk of complications.