# K161001: MILAGRO ADVANCE PEEK Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jun 9, 2016 after 59 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 8 generations back to K961555 (1996). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123362: Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 5.
- K143660: Milagro / Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2015) Summary page 5.

## Most influential descendants
- K240441: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw (2024), 1 descendant of its own
- K252022: OSSIOfiber® Interference Screw (2025), 0 descendants of its own

## Indications for use
The MILAGRO® ADVANCE PEEK 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 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/K161001
Methodology: https://510kreport.com/methodology