# K203259: FairFix Adjustable Button System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 26, 2021 after 141 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). 57 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) Summary page 4.
- K151037: GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle, Conmed Corporation (2015) Summary page 4.

## Most influential descendants
- K223795: FairFix QT Adjustable Button (2023), 0 descendants of its own
- K222169: FairFix Adjustable Button System (2022), 0 descendants of its own
- K221389: FairFix AM Adjustable Button  FairFix PSP Adjustable Button (2022), 0 descendants of its own

## Indications for use
FairFix Adjustable Button is intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5mm tunnel is realized. FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 – 11 mm tunnel.

Source page: https://510kreport.com/device/K203259
Methodology: https://510kreport.com/methodology