Treace Medical Gains FDA Clearance for Lapiplasty in Pediatric Patients

By Julie A. Vetalice

Treace Medical Concepts received FDA clearance to expand indications of the Lapiplasty® 3D Bunion Correction™ system to treat adolescent pediatric patients. Lapiplasty is designed to correct all three dimensions of bunion deformity and permanently secure the unstable tarsometatarsal joint, so patients can return to normal activity.

John T. Treace, CEO of Treace Medical, said, “Traditional osteotomy surgery has been associated with a high rate of recurrence, thus presenting a unique concern for younger patients. The Lapiplasty Procedure has clinically demonstrated high success rates in adults, and we believe this expanded indication will provide an important new treatment option for pediatric patients seeking a more comprehensive and lasting correction of their bunion.”

The ALIGN3D™ U.S. postmarket study of Lapiplasty, which commenced at the end of 2018, is a two-year prospective, multicenter, unblinded study of up to 200 patients, evaluating the procedure's ability to consistently correct three dimensions of bunion deformity and maintain correction following an accelerated return to weight-bearing. The primary endpoint is radiographic recurrence of the hallux valgus deformity at two-year follow up; secondary endpoints include change in three-dimensional radiographic alignment, clinical radiographic healing, time to start of weight-bearing in a boot and in shoes, pain, quality of life and range of motion of the big toe.

Source: Treace Medical Concepts, Inc.

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory