# K083648: Gotfried Physiological Hip (PH) Nail

- Pathway: 510(k) (Traditional)
- Applicant: Efratgo, Ltd. HI Tech Bio-Surgical
- Decided: May 14, 2009 after 156 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: 3 generations back to K981529 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040656: Modification to Smith & Nephew Intramedullary Hip Screw, Smith & Nephew, Inc. (2004) Summary page 1.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K043233: Gotfried Physiological Hip (PH) Nail, Efratgo, Ltd. HI Tech Bio-Surgical (2005) Summary page 1.

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

Source page: https://510kreport.com/device/K083648
Methodology: https://510kreport.com/methodology