As newer devices become increasingly important in the orthopedic industry, extremity and shoulder replacement implant testing has become an important part of many medical device manufacturer solutions. With a wide range of services, we are a single source provider for foot, ankle, extremity and shoulder implant device testing.
Element has extensive experience with shoulder replacement and extremity implant testing, including foot, ankle, wrist, elbow, and various other small joint orthopedics. Our team of Engaged Experts performs testing in accordance with recognized ASTM standard methods, as well as custom protocols for unique or novel designs. Through in-house testing and project management, our experts can assist in every stage of testing, from feasibility studies and test design to final regulatory submission.
Foot, Ankle and Shoulder Replacement Implant Test Methods
Our labs provide a full suite of testing services for foot, ankle, extremity and shoulder replacement implants, from mechanical testing to metallographic evaluation. Some of the methods that we offer include:
Flex and Bend Testing
Range of Motion
Glenoid Loosening Testing
Shoulder Implant Testing
Although shoulder replacements are less common than replacements of the lower extremities (such as knees and hips), total shoulder replacements can be very beneficial in eliminating the effects of arthritis, severe fractures, and other joint problems. Element performs fatigue testing, glenoid shear and glenoid loosening, and shoulder constraint testing to ASTM standards and custom protocols, and tests for shoulder replacement wear testing per unique, in-house methods.
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.
American Society for Testing and Materials
ASTM F1378, ASTM F1829, ASTM F2028, ASTM F2665, ASTM F1781, ASTM F1357, ASTM F2887
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Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.