# K223122: Menix®; Menix® Duo

- Pathway: 510(k) (Traditional)
- Applicant: S.B.M. Sas (Science & Bio Materials)
- Decided: Aug 3, 2023 after 304 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K050021 (2005). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N, Smith & Nephew, Inc. (2012) Summary page 4.

## Indications for use
The MENIX® / MENIX® DUO Meniscal Suture Systems are indicated for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The MENIX® / MENIX® DUO systems are indicated for use in meniscal repairs and allograft transplant procedures. The MENIX® / MENIX® DUO systems are intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures. The MENIX ® / MENIX® DUO devices are intended for single use only.

Source page: https://510kreport.com/device/K223122
Methodology: https://510kreport.com/methodology