# K073311: Osteotrans-OT Pin

- Pathway: 510(k) (Traditional)
- Applicant: Takiron Co., Ltd.
- Decided: May 13, 2008 after 172 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 6 generations back to K864912 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041288: Modification to Smartpin, Linvatec Biomaterials, Inc. (2004) Summary page 1.
- K031712: Inion Otps Biodegradable Pin, Inion, Ltd. (2003) Summary page 1.
- K010983: Plla Pin, Bionx Implants, Inc. (2001) Summary page 1.

## Indications for use
The OSTEOTRANSm-OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K073311
Methodology: https://510kreport.com/methodology