# K160804: INTRAFIX (TM) Advance Tibial Fastener System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 19, 2016 after 118 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
Longest line of descent: 7 generations back to K971358 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123362: Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 4.

## Indications for use
The DePuy Mitek INTRAFIX™ Advance Tibial Sheath and Screw System is indicated for fixation of tissue including ligament, or tendon to bone during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K160804
Methodology: https://510kreport.com/methodology