# K970097: Proximal Femoral Nail (PFN) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 13, 1997 after 59 days
- Product code: JDW (Pin, Fixation, Threaded)
- 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
No predicates in its family tree.
184 later devices descend from it; 8 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Howmedica’s Gamma Locking Nail (GLN): named in the summary without a submission number

## Most influential descendants
- K973240: Synthes Proximal Femoral Nail (PFN) System Modification (1997), 73 descendants of its own
- K983814: Gotfried Percutaneous Compression Plating System (1999), 71 descendants of its own
- K013563: Long Trochanteric Nail System (2001), 70 descendants of its own
- K010988: Fixion Interlocking Proximal Femoral Nailing System (2001), 59 descendants of its own
- K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System (2001), 56 descendants of its own

## Indications for use
The Synthes PFN System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fiacturcs high subtrochanteric fractures, and combinations of these fractures.

Source page: https://510kreport.com/device/K970097
Methodology: https://510kreport.com/methodology