# K122869: Milagro Interference Screws

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Dec 13, 2012 after 85 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: 10 generations back to K933738 (1994). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120589: Milagro Interference Screws, Depuy Mitek, A Johnson & Johnson Company (2012) Summary page 2.
- 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.
- K041356: Arthrex Tenodesis Screw Family, Arthrex, Inc. (2004) Summary page 1.
- K020043: 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw, Models AR-1555B, Arthrex, Inc. (2002) Summary page 1.

## Indications for use
The DePuy Mitek MILAGRO BR Interference Screws are designed to attach soft tissues to bone in orthopedic surgical procedures for following indications: Shoulder: Proximal Biceps Tenodesis, Acromlio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repair Knee: Collateral Ligament Repair

Source page: https://510kreport.com/device/K122869
Methodology: https://510kreport.com/methodology