OrthoPediatrics Corp. Receives FDA 510(k) Clearance for First Pediatric-Specific Foot System
WARSAW, Ind., Aug. 19, 2019 (GLOBE NEWSWIRE) — OrthoPediatrics Corp.(“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new PediFoot Deformity Correction System (“PediFoot”), the first pediatric-specific system to treat fractures and deformities of the foot and ankle.
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.”
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 7, 2019. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 29 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 43 countries outside the United States.
Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com
