# K983843: Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238B

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 12, 1999 after 133 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974847 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974847: 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture Anchor Model AR-22235, Arthrex, Inc. (1998) Summary page 1.

## Indications for use
The Arthrex Bio-Button is intended for the suture fixation of soft tissue to bone, utilizing the Arthrex® Corkscrew™ Suture Anchor and polyester braided sutures appropriate to the procedure, up to size 5 (single strand). This product is intended for use in repairing rotator cuff tears.

Source page: https://510kreport.com/device/K983843
Methodology: https://510kreport.com/methodology