# K933948: Acufex Endobutton System

- Pathway: 510(k) (Traditional)
- Applicant: Acufex Microsurgical, Inc.
- Decided: Jul 21, 1994 after 343 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
No predicates in its family tree.
317 later devices descend from it; 2 cite it directly.
0 of 318 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
- 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
- K033838: Titanium Toggle Button (S) (2004), 97 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own

Source page: https://510kreport.com/device/K933948
Methodology: https://510kreport.com/methodology