# K172830: Double Medical Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Aug 24, 2018 after 340 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: 4 generations back to K951740 (1995). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070761: Sanatmetal Nails and Pins, Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. (2008) Summary page 4.
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 4.

## Most influential descendants
- K253080: AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (2026), 0 descendants of its own
- K253046: HERA Interlocking Intramedullary Nailing System (2026), 0 descendants of its own

## Indications for use
Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing. Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include: – Pertrochanteric fractures (31-A1 and 31-A2); – Intertrochanteric fractures (31-A3); – High subtrochanteric fractures (32-A1). Indications for use of the Proximal Femoral Nail, Anti-rotation, long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include: – Low and extended subtrochanteric fractures; – Ipsilateral trochanteric fractures; – Combination fractures (in the proximal femur); – Pathological fractures. Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include: – Femoral shaft fractures. Indications for use of the Universal Femoral Nail II, Cannulated (UFN II) include: – Standard Locking UFN II: femoral shaft fractures; – Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures, subtrochanteric fractures.

Source page: https://510kreport.com/device/K172830
Methodology: https://510kreport.com/methodology