MINNEAPOLIS, Feb. 15 /PRNewswire/ -- Advanced Bio-Surfaces, Inc. (ABS), an orthopedic implant developer and manufacturer, announced today the company has been notified that its Technical File for the OrthoGlide Medial Knee Implant fulfills the requirements of the European Union's (EU) Medical Device Directive. The notification from the Notified Body, TUV Product Services (Munich), allows Advanced Bio-Surfaces to immediately begin applying the CE mark to the OrthoGlide Medial Knee Implant for sale in the EU.
The cobalt-chrome alloy composition of the innovative OrthoGlide implant has successfully passed functional and safety requirements. In addition, the implant's unique engineering design provides positional stability without the use of rigid fixation methods. The OrthoGlide has a specially contoured geometry which functions to provide an open glide path and allows for the unconstrained motion of the femoral condyle, while requiring less tissue and bone removal than current surgical options.
"Receiving the CE mark is another important milestone for Advanced Bio-Surfaces and the development of the OrthoGlide market. ABS is pleased with its achievement of obtaining FDA clearance to market and the CE mark," said Dr. Jeff Felt, Chairman and CEO of Advanced Bio-Surfaces. "The receipt of the CE mark enables us to offer the OrthoGlide implant to more patients in need of a better option for osteoarthritis."
Dr. Klaus Lehrberger from Munich, Germany said, "With this approval, ABS has made significant progress towards providing international orthopedic surgeons and their patients a better solution." Dr. Lehrberger continued, "For surgeons operating in the EU, the CE Mark is intended to ensure them and their patients of the product's safety."
About Advanced Bio-Surfaces, Inc.
ABS is a privately held company dedicated to the development of innovative joint repair products. The OrthoGlide Medial Knee Implant is the company's first product and is intended for treatment of patients with moderate osteoarthritis of the medial compartment. For additional information contact Robert Siegfried at 952.912.5400.
Advanced Bio-Surfaces, Inc.
CONTACT: Robert Siegfried, VP, Finance and Administration, of AdvancedBio-Surfaces, Inc., +1-952-912-5400