# K912420: Orthofix Unreamed Tibial Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Research
- Decided: Sep 23, 1991 after 115 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961027: Orthofix Tibial Nailing System (1996), 1 descendant of its own
- K973944: Orthofix Femoral Nailing Sytem (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K912420
Methodology: https://510kreport.com/methodology