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†Not available in the U.S. |
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Reliability
Independent testing completed by several laboratories, including Orthopaedic Research Laboratories,
confirms the reliability of the ROI & MC+ implants as intervertebral body replacement devices.
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Mechanical testing
Testing of the ROI and MC+® implants was completed by
independent laboratories in accordance with ASTM F 2077
(Test Methods for Intervertebral Body Fusion Devices).
This testing confirms that the ROI and MC+ provide the
necessary mechanical properties to provide primary
stability and distribution of loads along the spine
segment. These mechanical properties and design of the
implants provide conditions necessary for fusion.
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MC+ Static Axial Compression |
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Average Maximum Load |
7511 N |
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Standard Deviation |
633 N |
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Range |
6609 – 8154 N |
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MC+ Dynamic Compression Test |
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Frequency |
5 Hz |
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Load Cycle |
200 – 2000 N |
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Number of Cycles |
5,000,000 (without cracking or deformation) |
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MC+ Dynamic Torsion Test |
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Frequency |
5 Hz |
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Moment Load Cycle |
+/- 1000 N-mm |
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Number of Cycles |
5,000,000 (without cracking or deformation) |
Independent testing of ROI and
MC+ implants was completed by Orthopaedic Research
Laboratories, CRITT-MDTS and LNE.
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