The launch of PediFoot comes following 510(k) clearance from the US Food and Drug Administration in August.
OrthoPediatrics (NASDAQ:KIDS) has announced the launch of its PediFoot Deformity Correction System in the United States.
As quoted in the press release:
The PediFoot system is the first pediatric-specific system to treat deformities of the foot. Within the OrthoPediatrics product portfolio, this system offers the smallest plates and screws, which enable greater effectiveness in addressing cavus foot, flatfoot, clubfoot, and hallux valgus foot deformities. More specifically, the sophisticated system is designed to focus on lateral column lengthening, calcaneal slide osteotomies, opening and closing wedge osteotomies, and arthrodesis procedures. To optimize fixation in these procedures, PediFoot is the first OrthoPediatrics system to offer StarLoc™, a variable angle locking screw technology. In addition, patients will benefit from the innovative instrumentation which flexibly follows the anatomic movement of the bones during the correction process.
The system also includes PediPedal, a combination of non-slip platforms and handle that assist the surgeon in taking repeatable, simulated weight bearing x-rays intraoperatively during surgery.
“We are excited to commence the domestic launch of our PediFoot Deformity Correction System,” commented Joe Hauser, OrthoPediatrics’ Vice President of Trauma & Deformity Correction. “Designed with a team of eminent pediatric orthopedic surgeons, this system addresses four of the most common pediatric foot deformities. With a heightened focus on instrumentation and intra-operative ease, the entire system is contained in one tray with innovative instrumentation that aids in reproducible correction and optimizes time in the operating room. This is the first of many launches to address pediatric foot and ankle procedures.”