The Applied Technical Services (ATS) Family of Companies performs ASTM F2345 testing to validate the performance of a client’s ceramic modular femoral head sample.
On any given day, the hip experiences a great number of significant forces while supporting normal movement, meaning conditions that cause discomfort in this joint, such as arthritis, can severely impact quality of life. Hip replacement surgery, also referred to as total hip arthroplasty (THA), is a standard procedure designed to alleviate joint pain and stiffness while improving mobility and range of motion. Although rare, premature material fatigue created by the everyday forces exerted on a hip implant can cause the femoral head of the implant to fracture. This event poses a significant risk to the patient and typically requires emergency revision surgery. Medical device manufacturers pursue ASTM F2345 testing to mitigate this risk by assessing the effects of design dimensions, manufacturing processes, and material selection on the cyclic load-carrying potential of these components.
Our ASTM F2345 Testing Services
ASTM F2345 testing involves applying repeated loads to a hip implant device to simulate the wear accrued through normal activities over a long service life. This standard pertains to testing the fatigue strength of hip implants featuring a ceramic modular femoral head mounted to a metal cone to ensure it resists cracking under anticipated usage. Our medical device testing specialists submerge the assembly in a physiological solution and apply 10 million cycles of compressive load at varying levels of force like those the sample would experience over years of standing up, sitting down, walking around, and other regular movements. Technicians note whether the sample failed, the type of failure that occurred, and the number of cycles to failure, providing clients with the information they need to reformulate their materials, adjust their manufacturing processes, or make other improvements to help their product clear FDA approval.
The ATS Family of Companies (FoC) performs a variety of other medical implant testing services, including the following:
- Spinal Implants
- Knee Implants
- Shoulder System Implants
- Ankle System Implants
- Dental Implants
We perform testing and support clients navigating the FDA 510(k) or EU MDR approval processes, helping ensure the safety and efficacy of medical devices entering the market.
The ATS FoC: Taking You One Step Closer to Certainty
Since our founding in 1967, ATS has continually expanded the number of capabilities and improved the quality of service offered to our clients. In the decades since, we have expanded into a Family of Companies, leveraging expertise from around the country to deliver exceptional testing, inspection, calibration, and consulting excellence to clients in the medical industry. Our varied testing services also meet the needs of businesses in the following sectors:
- Aerospace
- Automotive
- Consumer Products
- Defense
- Insurance/Legal
- Manufacturing
Reach out to the ATS FoC today to learn more about how our ASTM F2345 testing capabilities can support your company at (888) 287-5227, or fill out the webform above to receive a free quote on our services.
