The OrthoGlide Implant has been developed, verified and validated in compliance with a comprehensive design process.

The OrthoGlide is manufactured using an investment casting, testing, evaluation and finishing process similar to other alloy metal orthopedic devices. The OrthoGlide is manufactured at Doncasters Medical Technologies, Inc., a manufacturer of other orthopedic devices.

Bench testing demonstrated the strength, durability and performance of the OrthoGlide by validation testing load deflection, cyclic fatigue resistance, material consistency and stability and process control. Cadaver evaluations verified the desired physiological effects of stability, angular correction and range of motion preservation.

Range of motion and stability were extensively evaluated on cadaver knees to verify range of motion preservation and stability of the device within the knee. The implant demonstrated desired range of motion in varus, neutral and valgus stress and provided the desired angular correction to the joint.

Simulated dislocation testing was performed to further demonstrate the stability of the OrthoGlide. A direct comparison was made to a predicate device, UniSpacer®. Each device was tested for anterior dislocation in six different cadaveric knees, which was repeated three times each. This resulted in a total of eighteen dislocation tests for each implant type. The results of the study showed that the OrthoGlide design required substantially greater force for anterior dislocation than did the predicate.