# K043233: Gotfried Physiological Hip (PH) Nail

- Pathway: 510(k) (Traditional)
- Applicant: Efratgo, Ltd. HI Tech Bio-Surgical
- Decided: Feb 1, 2005 after 71 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: 2 generations back to K954555 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983814: Gotfried Percutaneous Compression Plating System, Efratgo, Ltd. HI Tech Bio-Surgical (1999) Summary page 1.
- K970097: Proximal Femoral Nail (PFN) System, Synthes (Usa) (1997) Summary page 1.
- K034002: GAMMA3 Nail System, Howmedica Osteonics Corp. (2004) Summary page 1.

## Most influential descendants
- K083648: Gotfried Physiological Hip (PH) Nail (2009), 0 descendants of its own

## Indications for use
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur.

Source page: https://510kreport.com/device/K043233
Methodology: https://510kreport.com/methodology