# K905347: Hagie Pin

- Pathway: 510(k) (Traditional)
- Applicant: O'Tec Corp.
- Decided: Jan 4, 1991 after 37 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991649: Depuy Rockwood Clavicle Pin (1999), 15 descendants of its own
- K103001: Rockwood Clavicle Pins (2011), 7 descendants of its own
- K081832: Ensplintcmx Clavicle Pin (2008), 4 descendants of its own
- K143204: AOS Clavicle Intramedullary Device (2015), 2 descendants of its own
- K130298: Biopro Kwick-Wire Universal Screw System (2013), 2 descendants of its own

Source page: https://510kreport.com/device/K905347
Methodology: https://510kreport.com/methodology