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The qualified tool simulates screw pullout behavior in accordance with ASTM F543.
By: Michael Barbella
Mark Escobedo of WESTPAK offers insights on the revisions made to the latest protocol and how they could affect orthopedic device manufacturers.
A lack of clarity in ASTM standards for metal alloys for medical applications can create uncertainty.
The group plans to focus on standards development in five technical areas.
Guidance should bring testing of elbow in line with other large total joint techniques.
Ultimately, the proposed standard could improve the longevity and clinical performance of devices.
The standard also provides procedures for selecting the appropriate test soil for different kinds of devices.
Proposed standard would support potential for small “scaffolds” to regrow tissue around knee joint after a meniscus injury.
New structure allows standards to be developed at three levels.
The standard focuses on those used in unicondylar knee joint replacements.
Standard could help with efforts to use regenerative medicine for damaged knee cartilage.
A testing facility evaluates the pros and cons of the ASTM F2638 porous packaging test.
William Mihalko has distinguished career as physician and researcher.
New guide designed to help researchers and manufacturers comply with FDA regs.
Group also is working on a finite element guide for knee femoral components.
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