# K103831: Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Jul 21, 2011 after 203 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: 6 generations back to K971358 (1997). 12 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 31 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.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005). Our reading of the summary gave K001726, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Arthrex Tenodesis Screw Family”.
- 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.

## Most influential descendants
- K112249: Healix Knotless (TM) Anchor (2011), 13 descendants of its own
- K130917: Healix Advance Knotless BR Anchor (2013), 9 descendants of its own
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) (2013), 4 descendants of its own
- K131974: Healix Advance Knotless BR Anchor (6.5MM) (2013), 3 descendants of its own
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (2013), 3 descendants of its own

## Indications for use
The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows:

Source page: https://510kreport.com/device/K103831
Methodology: https://510kreport.com/methodology
