MENIX

Basic Information

• Brand Name: MENIX
• Primary DI: 03760304680533
• Version / Model: Meniscal suture system, 1 anchor
• Catalog Number: MEN0201902
• Company Name: S.B.M
• Labeler DUNS: 772462123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-11
• Public Version: 1
• Public Version Date: 2023-09-19
• Public Version Status: New
• Public Device Record Key: 99f89312-a725-4687-bce5-1fab2ca6134d

Device Description

MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66530	Meniscus suture anchor	A non-bioabsorbable, implantable device designed for suture-based meniscal tear repair and/or meniscus allograft stabilization. It is a small, bar-shaped, synthetic polymer device with holes for passing a suture, which is typically included. It is implanted using dedicated disposable arthroscopic instruments, which may be provided with the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760304680533	GS1

Premarket Submissions

Submission Number	Supplement Number
K223122	000