# K211049: Tigon Medical Button System

- Pathway: 510(k) (Traditional)
- Applicant: Tigon Medical
- Decided: Aug 4, 2021 after 118 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.
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)
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button, Arthrex, Inc. (2012) Summary page 4.

## Indications for use
The Tigon Medical Button System implants are intended to facilitate fixation of bone to bone or soft tissue to bone. Shoulder: Proximal Biceps Tendon Repair Minor Pectoralis Repair Major Pectoralis Repair Elbow: Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee: Anterior Cruciate Ligament Repair Posterior Cruciate Ligament Repair

Source page: https://510kreport.com/device/K211049
Methodology: https://510kreport.com/methodology