# K123362: Milagro Advance Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Feb 1, 2013 after 92 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971358 (1997). 9 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060830: Milagro Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 1.
- K032717: Biocryl Rapide Interference Screw, Mitek Worldwide (2004) Summary page 1.

## Most influential descendants
- K161001: MILAGRO ADVANCE PEEK Interference Screw (2016), 2 descendants of its own
- K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (2024), 1 descendant of its own
- K252022: OSSIOfiber® Interference Screw (2025), 0 descendants of its own
- K160804: INTRAFIX (TM) Advance Tibial Fastener System (2016), 0 descendants of its own
- K140324: Rigidloop Adjustable Cortical Implant: Standard, Long and XL (2014), 0 descendants of its own

## Indications for use
The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures. Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Source page: https://510kreport.com/device/K123362
Methodology: https://510kreport.com/methodology