FDA has granted a Breakthrough Device designation for the BioPoly Knee System. The BioPoly Knee utilizes the company’s proprietary BioPoly material which functions as synthetic cartilage. BioPoly plans to execute on their FDA-approved study with the BioPoly Knee System in the U.S. this year.
The BioPoly Knee 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.
The designation follows the U.S. introduction of the BioPoly Great Toe in 2021 and FDA 510(k) clearance of the BioPoly Lesser Toe in late 2022.
“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,” said 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.” said Justin J. Kaler, Vice President of Sales and Marketing.
FDA has granted a Breakthrough Device designation for the BioPoly Knee System. The BioPoly Knee utilizes the company’s proprietary BioPoly material which functions as synthetic cartilage. BioPoly plans to execute on their FDA-approved study with the BioPoly Knee System in the U.S. this year.
The BioPoly Knee is indicated for partial...
FDA has granted a Breakthrough Device designation for the BioPoly Knee System. The BioPoly Knee utilizes the company’s proprietary BioPoly material which functions as synthetic cartilage. BioPoly plans to execute on their FDA-approved study with the BioPoly Knee System in the U.S. this year.
The BioPoly Knee 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.
The designation follows the U.S. introduction of the BioPoly Great Toe in 2021 and FDA 510(k) clearance of the BioPoly Lesser Toe in late 2022.
“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,” said 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.” said Justin J. Kaler, Vice President of Sales and Marketing.
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