# K081390: Bioactif Osteotrans Interfence Screw

- Pathway: 510(k) (Traditional)
- Applicant: Takiron Co., Ltd.
- Decided: Aug 12, 2008 after 85 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 4 generations back to K971358 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003641: Biolok Screw, Biosteon Screw, Biocomposites, Ltd. (2001) Summary page 1.
- K002070: Biolok Screw, Biocomposites, Ltd. (2000) Summary page 1.
- K013572: Mitek Biocryl Interference Screws, Mitek Products (2002) Summary page 1.
- K002274: Smith & Nephew Suture Hapla Interference Screw, Smith & Nephew, Inc. (2001) Summary page 1.

## Indications for use
The BioactlF OSTEOTRANSTM Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.

Source page: https://510kreport.com/device/K081390
Methodology: https://510kreport.com/methodology