# K223795: FairFix QT Adjustable Button

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Jan 17, 2023 after 29 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: 10 generations back to K792022 (1979). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203259: FairFix Adjustable Button System, Medacta International S.A. (2021) Summary page 4.

## Indications for use
FairFix QT Adjustable Button is intended to be used with single ended graft, such as quad tendon graft, during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized. FairFix Extenders are intended to be used in association with FairFix QT Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø6 - 11 mm tunnel.

Source page: https://510kreport.com/device/K223795
Methodology: https://510kreport.com/methodology