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Accutek has extensive experience in a wide variety of medical implant testing. Accutek regularly performs static and dynamic testing for 510(k) submittals to successfully expedite products to market. Accutek's metallurgical experience and metallographic capabilities give our customers added value by providing immediate results for failure evaluations and product enhancements.

Some of the medical testing specifications Accutek commonly tests to are listed below. Our capabilities are not limited to these tests however.

ASTM Specification and Test Methods:

• F382 Metallic Bone Plates
• F564 Metallic Bone Staples
• F543 Metallic Medical Bone Screws
• F1044 Shear Testing of Porous Metal Coatings
• F1147 Tension Testing of Calcium Phosphate and Metallic Coatings
• F1223 Total Knee Replacement Constraint
• F1264 Intramedullary Fixation Devices
• F1440 Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
• F1541 External Skeletal Fixation Devices
• F1612 Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components With Torsion
• F1659 Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates
• F1717 Spinal Implant Constructs in a Vertebrectomy Model
• F1800 Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• F1814 Modular Hip and Knee Joint Components
• F1854 Stereological Evaluation of Pourous Coatings on Medical Implants
• F1978 Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
• F2077 Intervertebral Body Fusion Devices
• F2083 Total Knee Prosthesis (contact area)

ISO Specification and Test Methods:

• 7206-4 Determination of Endurance Properties of Stemmed Femoral Components
• 7206-6 Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components
• 7206-8 Endurance Performance of Stemmed Femoral Components with Application of Torsion
• 7206-10 Determination of Resistance to Static Load of Modular Femoral Heads

FDA - Various Guidance Doccuments