# K942442: Acufex T-Fix Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Acufex Microsurgical, Inc.
- Decided: Dec 5, 1994 after 196 days
- Product code: MIA (Needle, Spinal, Short Term)
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 3 cite it directly.
0 of 40 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
- K002261: MR-III (2000), 30 descendants of its own
- K092508: Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight, (2010), 17 descendants of its own
- K020480: RBM (2002), 16 descendants of its own
- K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems (2007), 15 descendants of its own
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N (2012), 12 descendants of its own

Source page: https://510kreport.com/device/K942442
Methodology: https://510kreport.com/methodology