BioPoly Gains FDA Clearance of Great Toe Implant

By Julie A. Vetalice

BioPoly Gains FDA Clearance of Great Toe Implant

BioPoly was granted FDA 510(k) clearance for the BioPoly® Great Toe Implant. BioPoly's technology is available for the first time in the U.S. First procedures are expected by the end of 2Q21.

BioPoly first received regulatory approval in 2012 for its knee implants in Europe. “Although we have been in patients in Europe with our knee implants for nearly 10 years, we are extremely excited to be able to enter the U.S. market with our BioPoly technology,” said Herb Schwartz, President of BioPoly.

The BioPoly Great Toe replaces a portion of the head of the first metatarsal bone and interacts with the opposite side of the joint so that only the damaged tissue is repaired. BioPoly surface properties are similar to cartilage; therefore, the frictional forces between BioPoly and cartilage are nearly the same as that of cartilage on cartilage.

BioPoly material is a microcomposite of polyethylene and hyaluronic acid. This proprietary combination results in a strong, hydrophilic material that offers an alternative to other surgical options such as fusion, metallic implants or polymeric spacers, one that is well-fixed in the bone and is robust enough to survive anatomical joint forces.

Sheila Schwartz, Vice President of Operations, said, “The 1st MTP (Great Toe) market needs an implant like BioPoly. With its unique ability to articulate with native cartilage, the BioPoly® Great Toe replaces only one side of the joint, allowing the healthy side to remain intact.”

 

Product Labels: Subtalar/Toe Replacement

Tags: 510(k) Clearance, Regulatory