OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Next Generation Cannulated Screw System
WARSAW, Ind., July 23, 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 next generation Cannulated Screw System for treating smaller stature patients with fractures and fusions.
The system was designed in collaboration with pediatric orthopedic surgeons focused on more solutions for treating pediatric patients with fractures. It expands the Company’s offering to help treat the unique needs found in pediatric hospitals and is expected to launch in the third quarter of 2019. The new screws are stainless steel and available in 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm and 5.5mm sizes. Further, this enhanced system offers an “all-in-one” kit option and is optimized to increase operating room efficiency.
OrthoPediatrics’ Executive Vice President, David Bailey, stated, “We are pleased with the FDA 510(k) clearance for our next generation cannulated screw system, which allows physicians to better treat smaller statures and patients at a younger age. This is truly innovative as it allows physicians to adequately address the issue when first detected/present, instead of waiting until the child grows to fit the tools available or repurposing adult products. Our engineering teams have been diligently working with a prominent group of surgeons, and we are excited to bring yet another system to market in our quest to partner with pediatric orthopedic surgeons.”
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 41 countries outside the United States.
Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com
