# K021782: BNF

- Pathway: 510(k) (Traditional)
- Applicant: Aap Implantate AG
- Decided: Aug 26, 2002 after 88 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K982601 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001)
- K011622: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws, Howmedica Osteonics Corp. (2001)
- K014220: T2 Femoral Nail System, Howmedica Osteonics Corp. (2002)
- K970733: Synthes Titanium Diastal Femoral Nail (TI DFN) System, Synthes (Usa) (1997) Summary page 2.
- K970097: Proximal Femoral Nail (PFN) System, Synthes (Usa) (1997) Summary page 2.
- K923597: Synthes Titanium Unreamed Femoral Nail, Synthes (Usa) (1993) Summary page 2.
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 2.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 2.
- K974781: Depuy Ace Aim (R) Titanium Supracondylar Nail, Depuy, Inc. (1998) Summary page 2.
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 2.
- K013923: Titanium Retrograde Femoral Nail - 13 MM Diameter, Biomet Orthopedics, Inc. (2002)

## Indications for use
Types of Fractures: Simple Closed Fractures Comminuted Fractures Open Fractures of First, Second or Third Degree Crush Fractures Antegrade Indications: Femur Shaft Fractures Distal Femur Shaft Fractures Pathological Fractures (e.g. Tumor Osteolysis) Periprosthetic Femur Fracture in the Middle of Third Part with Knee Replacement in Situ Retrograde Indications: Supracondylary Fractures Simultaneous Nailing of Femur and Tibia Distal Femur Fracture with Osteosynthesis or Hip Prosthesis in Situ Periprosthetic Femur Fracture at Knee Arthosplasty Borderline Indications: Percondylar Femur Fracture,

Source page: https://510kreport.com/device/K021782
Methodology: https://510kreport.com/methodology