Foot, Ankle and Shoulder Replacement Implant Testing

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:

Fatigue Testing

Flex and Bend Testing

Shear Testing

Wear Testing

Particulate Analysis

Range of Motion

Feasibility Studies

Porous Coating Evaluation

Glenoid Loosening Testing

Constraint Testing

Multi-axis testing

Shoulder Replacement Testing 640 x 480 May 2018

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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.

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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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Our Medical Device Testing Services

Accelerated Aging Shelf Life Testing Cardiovascular Device Testing Chemical Compatibility Testing Clinical Validation Testing Container and Package Testing Dental Implant Testing Electrochemical Corrosion Testing Extractables and Leachables Testing EMC Testing of Medical Devices

IEC 60601 Medical Device Safety Testing ISO 10993-18 Chemical Characterization ISO 18562 Biocompatibility Analysis Medical Device Battery Testing Medical Device Directive Safety Testing Medical Regulatory Affairs Microbiological Testing Orthopedic Device Testing Pin on Disk Wear Testing

Porous Coating Testing Prefilled Syringe Testing Rated Burst Pressure and Leak Testing Reusable Medical Device Life Cycle Validation Reusable Medical Device Reprocessing and Testing Stent and Graft Testing Wear Testing of Medical Devices

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Maciej Jakucki

Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.

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