As with all other segments, mechanical testing is a crucial component for proving equivalence or superiority to a predicate device when seeking regulatory approval.
Element has extensive experience with extremity implant testing, including shoulder, foot, ankle, hand, and various other small joint orthopaedics. Our team of Engaged Experts performs testing in accordance with recognized ASTM standard methods as well as custom protocols for unique or novel designs.
Shoulder Implant Testing
Although shoulder replacements are less common than replacements of the lower extremities such as knees and hips, total shoulder replacement surgery can be very beneficial in eliminating the effects of arthritis, severe fractures, and other joint problems. Element performs fatigue testing, glenoid shear, glenoid loosening, and shoulder constraint testing. Although no standard currently exists for should implant wear testing, our Engaged Experts can perform wear testing on shoulder prostheses utilizing internal protocols.
Foot and Ankle Implant Testing
With recent advances in the design of total ankle replacements, the American Academy of Orthopaedic Surgeons (AAOS) states “total ankle replacement (TAR) is fast becoming the treatment of choice for many patients with ankle arthritis and other disorders.” As a result, Element offers ankle replacement testing, including fatigue, constraint, and wear testing in accordance with ASTM F2665.
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Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.
Kent is the co-founder of Medical Device Testing Services, acquired by Element in 2017. Kent’s expertise in medical device testing has led to the development of new test instruments, standards and protocols.