Menix Duo
by S.B.M. Sas (Science & Bio Materials) EUDAMED510(k)
Active
510(k) K223122
Overview
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.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK223122 | Date3 Aug 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Menix®; Menix® Duo
- 510(k) Number
- FDA Product Code
- GAT
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5000
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from S.B.M. Sas (Science & Bio Materials)
Questions
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.