# K190288: Arthrex Tenodesis Button

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 13, 2019 after 214 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: 8 generations back to K792022 (1979). 58 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button, Arthrex, Inc. (2012) Summary page 4.

## Most influential descendants
- K192750: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip (2020), 3 descendants of its own
- K202259: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip (2020), 2 descendants of its own
- K213018: Auxilock GFS Mini, GFS II Large, and GFS Ultimate (2022), 0 descendants of its own
- K212739: ActiFlip (2021), 0 descendants of its own

## Indications for use
The Tenodesis Button is used for fixation of bone to bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

Source page: https://510kreport.com/device/K190288
Methodology: https://510kreport.com/methodology