BioPoly® Announces FDA Breakthrough Device Designation of the BioPoly Knee System
FORT WAYNE, IN – BioPoly LLC announced today the FDA has granted the company a Breakthrough Device designation for its BioPoly Knee System. The company plans to execute on their FDA-approved study with the BioPoly Knee System in the US this year. The BioPoly Knee System utilizes the company’s proprietary BioPoly material which functions as synthetic cartilage.
“This is a big milestone and achievement for the company and BioPoly team”, says Ryan Schlotterback, President & CEO of BioPoly. “We’re excited about the Breakthrough Device designation and the potential to accelerate our BioPoly Knee System into the US market. We have a tremendous amount of clinical experience in Europe with great results and look forward to expanding here in the US. Achieving this designation was an important part of our strategy.”
The BioPoly Knee System is indicated for partial resurfacing in the femoral condyle or trochlear facet. The implants are indicated for use with or without bone cement and provide surgeons an early intervention option to address cartilage damage using bone sparing and minimally invasive techniques. “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. I am thrilled that the BioPoly Knee System has been recognized by the FDA as a Breakthrough Device, and we now have the ability to move quickly through the regulatory process with our FDA-approved clinical study,” says Herb Schwartz, Founder and CTO of BioPoly.
“I’m incredibly grateful for all the hard work and dedication from our engineering and operation teams over the last decade. Combined with the rapid growth of our U.S. sales channel this year, this decision by the FDA continues to build confidence and excitement in our strategic direction. With our growing portfolio of BioPoly extremity products, I’m thrilled that we will soon have the potential to be adding large joint resurfacing solutions to our call pattern.” says Justin J. Kaler, Vice President of Sales and Marketing.
About BioPoly LLC
BioPoly LLC is an ISO 13485 certified orthopedic implant manufacturer located in Fort Wayne, Indiana. The Company develops, manufactures, and markets orthopedic implants that use its proprietary BioPoly material to replace damaged cartilage in joints. BioPoly currently has multiple FDA cleared products and is actively developing additional products for the US market.