Implant Testing Services

The United States Food and Drug Administration (FDA) regulations are placing ever more stringent demands on implant manufacturers. The need for authoritative, independent test data, which completely characterize prosthesis performance, has never been greater. Theken Orthopaedic conducts tests in GLP approved laboratories, in accordance with ASTM F-4 standards. We provide the full range of tests required for orthopaedic implants including static and fatigue (endurance) tests on either individual component or assembled constructs.

Theken Orthopaedic has one of the most technologically advanced implant testing facilities in the world, which incorporates several uniaxial and biaxial digital servo hydraulic test systems controlled through high-speed computers. The testing configurations capable on these machines are endless, while the type of implant material tested ranges from titanium to polymer composites. At our state-of-the-art facilities, we have performed mechanical testing for some of the biggest and best names in the orthopaedic business world. Theken Orthopaedic exclusively tests medical implants and devices. This commitment to medical device testing has given us the highest reputation throughout the business world.

Theken Orthopaedic provides one of the most comprehensive technical testing reports the medical industry has ever seen. We have a 99% acceptance rate of approval from the FDA for 510(k) testing submissions. This outstanding acceptance rating has provided us the opportunity to work with some of the largest medical implant manufacturers in the world. Please feel free to visit our implant testing facilities today, or call with any questions you might have.