# K914453: Universal Tibial Nail and Unreamed Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 18, 1992 after 137 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
118 later devices descend from it; 13 cite it directly.
0 of 119 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
- K990717: Fixion Intramedullary Nailing System (1999), 56 descendants of its own
- K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System) (2002), 54 descendants of its own
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System (2001), 54 descendants of its own
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail (2002), 53 descendants of its own
- K013430: Ace Bio Win Tibial Nailing System (2001), 48 descendants of its own

Source page: https://510kreport.com/device/K914453
Methodology: https://510kreport.com/methodology