OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Pediatric Nailing Platform | Tibia
11 Septembre 2023 - 10:05PM
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
Pediatric Nailing Platform | Tibia (“PNP Tibia”) surgical system.
Part of the Trauma & Deformity Correction
suite of products, PNP Tibia represents another pediatric-focused
solution for treating patients with fractures and deformities in
the lower extremities. It expands the Company’s offering to 51
unique surgical systems designed specifically to help treat the
needs of pediatric patients and is expected to launch in the third
quarter of 2023. The PNP Tibia System features rigid
cannulated nails, ranging in diameters from 7mm-12mm, and includes
specialized instrumentation to facilitate multiple surgical
techniques. Like other OrthoPediatrics products, this system was
designed for children’s anatomy and growing patients.
Joe Hauser, President of OrthoPediatrics’ Trauma
& Deformity Correction business stated, “We are pleased with
the FDA 510(k) clearance for our new PNP Tibia System, which allows
physicians to better treat children with implants and instruments
that are made for their unique anatomy and musculoskeletal
conditions. Our engineering team developed this first of its kind
system in close collaboration with a group of renown surgeons to
address the most common challenges they face in tibial trauma and
deformity cases. The PNP Tibia System expands our Pediatric Nailing
Platform, which has quickly become the market leader and is our
largest trauma product. We are excited by its growth prospects and
to bring yet another system to market in our effort to surround our
surgeon customers with everything they need to help KIDS.”
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 51 surgical systems that serve three of the
largest categories within the pediatric orthopedic market. This
product 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 over 70 countries
outside the United States. For more information, please visit
www.orthopediatrics.com.
Investor ContactPhilip Trip
TaylorGilmartin Groupphilip@gilmartinir.com415-937-5406
OrthoPediatrics (NASDAQ:KIDS)
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