# K143660: Milagro / Milagro Advance Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: May 21, 2015 after 149 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 K961555 (1996). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an, Smith & Nephew, Inc. (2012) Summary page 4.
- K093428: Smith & Nephew Knotless Instability Anchor, Smith & Nephew Endoscopy, Inc. (2009) Summary page 4.

## 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
- K210122: Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (2021), 0 descendants of its own

## Indications for use
Milagro Interference Screw (5x12, 6x12, 7x15, 8x15) The MILAGRO BR Interference Screws are designed to attach soft tissues to bone in Orthopedic surgical procedures for the following indications: Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation) Milagro Advance Interference Screw (7x23, 8x23, 9x23) 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 9mm x 23mm screws are indicated for: medial and lateral collateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Source page: https://510kreport.com/device/K143660
Methodology: https://510kreport.com/methodology