OrthoPediatrics Receives FDA Clearance for Pediatric-Specific Foot System

OrthoPediatrics (NASDAQ:KIDS) has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) For its PediFoot Deformity Correction System.

As quoted in the press release:

This system consists of innovative implants and instrumentation that increase procedure throughput. PediFoot is the first OrthoPediatrics’ system to incorporate the StarLoc™ variable angle locking technology, [which features a unique star-shaped design to offer five points of fixation], while also being the thinnest plates in the portfolio. OrthoPediatrics’ PediFoot Deformity Correction System is intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments, including hands, wrists, feet, and ankles. Common pediatric deformities that this system addresses include cavus foot, flatfoot, clubfoot, and hallux valgus.

OrthoPediatrics’ Vice President, Joe Hauser, stated, “The 510(k) clearance for our PediFoot system is an exciting milestone for the OrthoPediatrics’ Trauma & Deformity Correction business. As we continue to develop innovative new products, we are working to ensure that pediatric orthopedic surgeons have the right instrumentations needed to treat children with orthopedic conditions. This system closes a gap in the marketplace and our portfolio, providing surgeons with novel technologies to treat four of the most common pediatric foot deformities as well as fractures of the foot and ankle. Our engineers worked closely with a great surgeon design team, and we are excited to launch this system in the third quarter.”

Click here to read the full press release.