# K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek
- Decided: Mar 15, 2024 after 30 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 K961555 (1996). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 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 10.
- K143660: Milagro / Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2015) Summary page 11.
- K123362: Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 11.
- K161001: MILAGRO ADVANCE PEEK Interference Screw, Medos International SARL (2016) Summary page 11.

## Most influential descendants
- K252022: OSSIOfiber® Interference Screw (2025), 0 descendants of its own

## Indications for use
MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm): The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows: » Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. » Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction » Knee: Medial and lateral collateral ligament repair » Knee: Medial patellofemoral ligament reconstruction (femur fixation) * Shoulder: Proximal Biceps Tenodesis * Elbow: Distal Biceps Tenodesis * Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm): The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows: » Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. » Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction * Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm): The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows: » Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. » Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction » Knee: Medial and lateral collateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation) * Shoulder: Proximal Biceps Tenodesis * Elbow: Distal Biceps Tenodesis * Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm): The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows: » Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. » Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction * Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm): The DePuy Mitek MILAGRO BR Interference Screws 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) * Foot and Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Tendon Transfer in the Foot and Ankle MILAGRO BR Interference Screws (5x23mm, 5x30mm, 6x23mm, 6x30mm): The DePuy Mitek MILAGRO Interference Screw is indicated as follows: » Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures » Knee: Medial and lateral collateral ligament repair* * Shoulder: Proximal bicep tenodesis* * Elbow: Distal bicep tenodesis* * Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle * These indications do not apply to 5x30mm Screws and 6x30mm Screws

Source page: https://510kreport.com/device/K240441
Methodology: https://510kreport.com/methodology