# K180243: Infinity-Lock Button System

- Pathway: 510(k) (Traditional)
- Applicant: Xiros, Ltd.
- Decided: Apr 3, 2018 after 64 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: 7 generations back to K792022 (1979). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 5.

## Indications for use
The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates. The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.

Source page: https://510kreport.com/device/K180243
Methodology: https://510kreport.com/methodology