# K130716: Bioretec Activascrew Interference

- Pathway: 510(k) (Traditional)
- Applicant: Bioretec, Ltd.
- Decided: Aug 28, 2013 after 166 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 K792022 (1979). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071464: Inion Hexalon Biodegradable Acl/PCL Screw, Inion OY (2007) Summary page 2.
- K010525: Arthrex Tenodesis Screw 7MM, 8MM, 9MM, Arthrex, Inc. (2001) Summary page 2.
- K011007: Tenodesis Screw, 5.5 MM, Model AR-1350-55, Arthrex, Inc. (2001) Summary page 2.
- 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 2.
- K041356: Arthrex Tenodesis Screw Family, Arthrex, Inc. (2004) Summary page 2.
- K051726: Arthrex Tenodesis Family, Arthrex, Inc. (2005) Summary page 2.
- K062980: Activascrew, Bioretec, Ltd. (2006) Summary page 2.
- K072848: Activascrew, Bioretec, Ltd. (2007) Summary page 2.
- K081392: Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with Activapin, Bioretec, Ltd. (2008) Summary page 2.

## Indications for use
The ActivaScrew Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.

Source page: https://510kreport.com/device/K130716
Methodology: https://510kreport.com/methodology