# K120589: Milagro Interference Screws

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Apr 24, 2012 after 56 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: 9 generations back to K933738 (1994). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103831: Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 2.
- K060830: Milagro Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 2.
- K032717: Biocryl Rapide Interference Screw, Mitek Worldwide (2004) Summary page 1.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 1.
- K102410: Matryx Interference Screw (5.0-6.5MM), Conmed Linvatec (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K041356: Arthrex Tenodesis Screw Family, Arthrex, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K020043: 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw, Models AR-1555B, Arthrex, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122869: Milagro Interference Screws (2012), 0 descendants of its own

## Indications for use
The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.

Source page: https://510kreport.com/device/K120589
Methodology: https://510kreport.com/methodology