# K161327: Syntec Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corporation
- Decided: Jun 8, 2017 after 392 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
Longest line of descent: 6 generations back to K000684 (2000). 71 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail, I.T.S. GmbH (2014) Summary page 4.

## Most influential descendants
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own
- K202935: Syntec Femoral Nail Extended System (2020), 0 descendants of its own
- K191617: Syntec Tibial Nail System (2019), 0 descendants of its own

## Indications for use
THE SYNTEC HUMERAL NAIL SYSTEM IS INDICATED FOR FRACTURES OF THE PROXIMAL HUMERUS, INCLUDING 2-PART SURGICAL NECK FRACTURES, 3-PART FRACTURES, AND 4-PART FRACTURES, PROXIMAL HUMERAL FRACTURES WITH DIAPHYSEAL EXTENSION INTO THE SHAFT, AND IMPENDING PATHOLOGIC HUMERAL FRACTURES.

Source page: https://510kreport.com/device/K161327
Methodology: https://510kreport.com/methodology