# K073312: Osteotrans-OT Screw

- Pathway: 510(k) (Traditional)
- Applicant: Takiron Co., Ltd.
- Decided: May 13, 2008 after 172 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 K792022 (1979). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.
- K020222: Wisorb Malleolar Screw, Cambridge Scientific, Inc. (2002) Summary page 1.
- K040265: Little Grafter Screw, Biocomposites, Ltd. (2004) Summary page 1.

## Indications for use
The OSTEOTRANS M-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.

Source page: https://510kreport.com/device/K073312
Methodology: https://510kreport.com/methodology