# K190582: MicroLink All-Suture Button Fixation System (Radiopaque)

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jun 28, 2019 after 114 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 12 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)
- K140328: CMC Mini Tightrope, Arthrex, Inc. (2014) Summary page 4.

## Indications for use
Intended Use The MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Indications for Use The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures: Procedure Anatomic Location Carpometacarpal Suspension Hand

Source page: https://510kreport.com/device/K190582
Methodology: https://510kreport.com/methodology
