# K033071: Synthes (Usa) Cannulated Titanium Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 5, 2003 after 37 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 6 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103002: Synthes Multiloc Proximal Humeral Nailing System (2011), 17 descendants of its own
- K120807: Synthes Multiloc Humeral Nailing System (2012), 15 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 3 descendants of its own
- K192003: Auxein Nailing System (2020), 2 descendants of its own

## Recalls of this device
- Jul 30, 2013 · Class II · Z-0407-2014: The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
- Nov 2, 2012 · Class II · Z-2058-2013: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external 

## Indications for use
The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include: Diaphyseal fractures of the humeral shaft Fractures of the proximal humerus Proximal humeral fractures with diaphyseal extension Impending pathologic fractures Malunions and nonunions

Source page: https://510kreport.com/device/K033071
Methodology: https://510kreport.com/methodology