# K181296: Syntec Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corporation
- Decided: Apr 11, 2019 after 330 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: 7 generations back to K000684 (2000). 74 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040462: Trigen Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2004) Summary page 4.
- K161327: Syntec Humeral Nail System, Syntec Scientific Corporation (2017) Summary page 4.
- 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.

## Most influential descendants
- 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 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/K181296
Methodology: https://510kreport.com/methodology