We can help you gain regulatory approval for your ankle devices
OIC offers a broad range of static, dynamic, computational, and wear testing services for total ankle replacement devices. All of our test procedures follow international test standards as described below.
Our engineering team is active in ASTM and ISO arthroplasty standards committees to ensure the latest industry best-practices are applied to your test. If a non-standard test is needed, our engineering team will develop and incorporate modifications to suit your specific device and data needs.
Having a strong foundation in clinical research provides you with the additional value of a clinically-relevant test procedure. We pride ourselves on the ability to meet a customer’s specific needs with a wholly unique, tailored solution.
Total Ankle Specifications
Outlines the specifications for ankle components and characteristics important to in vivo performance. These include: tibial tray fatigue with reference to ASTM F1800, contact area and contact pressure analysis, range of motion assessment, device constraint evaluation with reference to ASTM F1223, static and dynamic shear tests, bending tests and tensile tests, wear testing, and coating strength tests.
Wear of Total Ankle-Joint Prostheses
Wear performance of total ankle replacements (TAR) is assessed via loading and displacement parameters as specified in ISO 22622. Up to 6 systems can be assessed on OIC’s AMTI knee simulator. Samples complete 5 million cycles of testing, and wear is measured through gravimetric analysis following ISO 14243-2. Typical add-ons for this test are accelerated aging of polyethylene components, wear particle characterization, surface roughness characterization, and CMM measurements to evaluate dimensional changes resulting from the test. Adverse condition testing is also commonly performed to evaluate TAR device performance under non-ideal conditions such as increased load, high range of motion, and roughened or pre-damaged articular inserts.