# K202935: Syntec Femoral Nail Extended System

- Pathway: 510(k) (Special)
- Applicant: Syntec Scientific Corporation
- Decided: Oct 28, 2020 after 29 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)
- K181296: Syntec Femoral Nail System, Syntec Scientific Corporation (2019) Summary page 5.
- 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 5.

## Indications for use
The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures: Delayed union fractures: Open and closed femur shaft fractures; Combined inter and subrochanteric fractures: High subtrochanteric fractures: Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and tumor resections: Pertrochanteric fractures; and Nonunions and malunions.

Source page: https://510kreport.com/device/K202935
Methodology: https://510kreport.com/methodology