# K973240: Synthes Proximal Femoral Nail (PFN) System Modification

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 20, 1997 after 84 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970097 (1997). 1 ancestor in all.
73 later devices descend from it; 2 cite 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)
- K970097: Proximal Femoral Nail (PFN) System, Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K013563: Long Trochanteric Nail System (2001), 70 descendants of its own
- K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems (2003), 53 descendants of its own
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails (2010), 29 descendants of its own
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own

## Indications for use
The Synthes modified PFN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal non-unions and malunions and revision procedures.

Source page: https://510kreport.com/device/K973240
Methodology: https://510kreport.com/methodology