Fort Wayne Company Secures FDA Clearance
(photo courtesy of BioPoly LLC)
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowFort Wayne-based BioPoly LLC has announced that the U.S. Food and Drug Administration has granted clearance for its BioPoly Great Toe Implant. With the clearance, the orthopedic manufacturer says the technology is available for the first time in the U.S.
BioPoly says it 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 US market with our BioPoly technology,” said Herb Schwartz, president of BioPoly. “We have a porous and non-porous stem design and are moving very quickly to get sterile product to the shelf. The plan is to be ready for first surgeries by the end of 2nd Quarter 2021. Our team has accomplished some amazing feats here. I am very proud of them.”
The manufacturer says the implant 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.” Testing results found that BioPoly material is more “cartilage-friendly” than metallic implant materials, causing less cartilage wear.
The company says it plans to obtain FDA clearance for additional BioPoly orthopedic applications in the future.