# K191617: Syntec Tibial Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corporation
- Decided: Sep 3, 2019 after 77 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: 8 generations back to K000684 (2000). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984543: Syntec-Taichung Non-Sterile Interlocking Nail System, Model:Humerus:256-000/280, Femur:274-000/870, Tibia:249-300/420 25, Syntec Scientific Corp. (1999) Summary page 4.
- K181296: Syntec Femoral Nail System, Syntec Scientific Corporation (2019) Summary page 4.
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 4.

## Indications for use
The Syntec Tibial Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; certain pre- and post-isthmic fractures; open and closed tibial shaft fractures; and tibial malunions and non-unions

Source page: https://510kreport.com/device/K191617
Methodology: https://510kreport.com/methodology