# K053492: Bioduct

- Pathway: 510(k) (Traditional)
- Applicant: Bioduct, LLC
- Decided: Apr 12, 2007 after 483 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: 2 generations back to K925573 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002406: Mitek 2GII Meniscal Repair System, Mitek Products (2001) Summary page 1.
- K991715: Biostinger-V Bioabsorbable Meniscal Repair Device, Linvatec Corp. (1999) Summary page 1.
- K980681: Innovasive Devices Meniscal Screw, Innovasive Devices, Inc. (1998) Summary page 1.
- K955768: Biofix Biodegradable Meniscus Arrow System, Bioscience, Inc. (1996) Summary page 1.
- K003070: Ethibond Excel Valve Loop Suture, ETHICON, Inc. (2000) Summary page 1.
- K983577: Arthrex Meniscal Dart System, Arthrex, Inc. (1999) Summary page 1.

## Indications for use
BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.

Source page: https://510kreport.com/device/K053492
Methodology: https://510kreport.com/methodology