FDA OKs Forma Medical’s OptimalMTP Plating System

Forma Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its OptimalMTP plating system. The company regards it as a significant leap forward in minimally invasive surgery.

OptimalMTP is a plate and screw system dedicated to less invasive MTP (metatarsal phalangeal) fusion of the first ray. The flagship system, along with Forma’s OptimalHT and OptimalAkin forefoot products aim to address complex orthopedic challenges in a less invasive manner than the current standard of care.

The Camp Hill, Pa.-based company focuses on bunion-adjacent procedures and works to set new standards for minimally invasive surgical solutions in foot and ankle surgery.

OptimalHT rolled out in September 2023. The instrumented MIS hammertoe arthrodesis procedure is less invasive than other hammertoe-specific products on the market, according to Forma Medical. The company also boasted that OptimalHT is more cost-effective and scalable than other attempts at hammertoe-specific products.

“The FDA clearance of our Optimal Plating System marks a pivotal moment for Forma Medical and the orthopedic community at large,” said Chris Cole, VP of sales at Forma Medical. “We are excited to introduce a transformative platform that not only enhances surgical outcomes but also elevates the standard of care for patients undergoing orthopedic foot and ankle procedures.”