# K193165: MectaFix CL Fixation Button with Continuous Loop

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Feb 10, 2020 after 87 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K792022 (1979). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081098: Endobutton Continuous Loop (CL), Smith & Nephew Inc., Endoscopy Division (2008) Summary page 4.

## Indications for use
The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K193165
Methodology: https://510kreport.com/methodology