# K922559: Acufex Endofix Button

- Pathway: 510(k) (Traditional)
- Applicant: Acufex Microsurgical, Inc.
- Decided: Dec 24, 1992 after 209 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
349 later devices descend from it; 2 cite it directly.
0 of 350 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980155: Endobutton Continuous Loop (1998), 347 descendants of its own
- K984550: Pre-Threaded Endobutton (1999), 310 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own

Source page: https://510kreport.com/device/K922559
Methodology: https://510kreport.com/methodology