ROI® Reliability
Independent testing completed by several laboratories, including
Orthopaedic Research Laboratories, confirms the reliability of the ROI & MC+ implants
as intervertebral body replacement devices.
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.
|
ROI Static Axial Compression Test |
|
| Average Maximum Load | 17014 N |
| Standard Deviation | 944 N |
| Range | 15685 – 18481 N |
|
ROI Dynamic Compression Test |
|
| Frequency | 5 Hz |
| Load Cycle | 510 – 5100 N |
| Number of Cycles | 5,000,000 (without cracking or deformation) |
| ROI Dynamic Torsion Test | |
| Frequency | 5 Hz |
| Moment Load Cycle | +/- 2400 N-mm |
| 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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