SpeedPlate Gets 510(k) Clearance for Bunion and Foot Fracture Repair

The FDA granted 510(k) clearance to Treace Medical Concepts’ SpeedPlate rapid compression implant system for bunion repair as well as foot and ankle fracture and joint repair surgeries.

The system uses titanium compression implants along with the company’s Micro-Lapiplasty instrumentation. This combination allows for lapiplasty, a bunion correction procedure, to be performed through 2cm incisions. The company says the smaller incisions and reduced tissue dissection should mean that patients recover more quickly with less pain and swelling.

A bunion is a complex 3-dimensional deformity resulting from an unstable joint in the middle of the foot. The condition affects approximately 65 million Americans, of which 1.1 million are candidates for surgery each year.

The company is planning a limited release of SpeedPlate implants with Micro-Lapiplasty instrumentation in the first half of 2023 and expanded access in the second half.