Fort Wayne ortho firm receives key designation for knee system
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Orthopedic implant manufacturer BioPoly LLC says it has received a Breakthrough Device designation from the U.S. Food and Drug Administration for its BioPoly Knee System. The Fort Wayne company says the designation allows for a sped-up approval process for devices that provide for “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
The system says the implant utilizes the company’s proprietary BioPoly material which functions as synthetic cartilage. BioPoly says the knee system is used for partial resurfacing in the femoral condyle, which is located on the end of the thigh bone.
“With our innovative synthetic cartilage material, the BioPoly team has developed a very eloquent, yet effective, implant system which has been proven to reduce pain and improve quality of life for patients,” said Herb Schwartz, founder and chief technology officer of BioPoly. “We now have the ability to move quickly through the regulatory process with our FDA-approved clinical study.”
The designation allows manufacturers to connect with FDA experts throughout the regulatory process and create a smoother path for FDA approval and placement in the market.
BioPoly says it has a “tremendous amount” of clinical experience in Europe and looks forward to expanding here in the US.