BioPoly Lesser Toe Hemiarthroplasty Implant

BioPoly Lesser Toe Hemiarthroplasty Implant is an FDA 510(k)-cleared medical device (K222964) manufactured by BioPoly, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2022. Regulation: 8.