LEWISVILLE, Texas–(BUSINESS WIRE)–Jul 20, 2020–
Orthofix Medical Inc. (NASDAQ:OFIX), a worldwide medical system firm centered on musculoskeletal therapeutic merchandise, as we speak introduced it has obtained the U.S. Meals and Drug Administration (FDA) 510(okay) clearance and European CE Mark approval for the JuniOrtho ® Plating System. Created particularly for pediatric sufferers, this revolutionary fixation system is designed to deal with the calls for of superior deformity and trauma reconstruction of the decrease extremities.
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Picture of the Orthofix JuniOrtho Plating System (Picture: Enterprise Wire)
“The sector of deformity correction is quickly evolving with a number of technical and technological advances yearly,” stated Dr. Philip McClure, an orthopedic surgeon on the Worldwide Heart for Limb Lengthening in Baltimore. “Exterior fixators are an extremely highly effective instrument in caring for deformities in youngsters around the globe. Improved designs of inner fixation units have allowed us to supply complimentary choices to exterior fixators to learn our sufferers and their households. Our objective is to acquire the absolute best end result so youngsters can take pleasure in their lives after deformity correction surgical procedure.”
The JuniOrtho Plating System is complemented by a pre-operative planning software program possibility that streamlines the implant choice previous to the surgical process. This distinctive platform allows the surgeon to precisely plan the osteotomy place to visualise the implant in relation to the anatomy. This aids within the collection of the exact measurement of system to make sure the very best match and optimum positioning for the affected person’s physique. Particularly developed for use together with the JuniOrtho Plating System, the software program is at the moment out there in Europe and deliberate for launch within the U.S. later this yr.
“The JuniOrtho Plating System represents our continued dedication to advancing pediatric orthopedics by offering surgeons the units they should deal with even the smallest of sufferers,” stated Jon Serbousek, President and CEO of Orthofix. “We’re excited to now be capable of provide surgeons each an inner and exterior fixation methods to develop our portfolio of pediatric deformity care options.”
Supplied in a variety of plate sizes with a wide range of lengths, the JuniOrtho Plating System accommodates each locking and non-locking screws akin to the plate measurement. The system is comprised of sterile implants and single-use instruments to cut back the danger of contamination and optimize effectivity through the process.
The JuniOrtho Plating System is a part of the JuniOrtho line of pediatric options that features the TL-HEX™ system, TrueLok Ring Fixation System, eight-Plate Guided Growth System+, and lots of others. JuniOrtho brings merchandise and sources collectively to present medical professionals and households alike the very best in pediatric orthopedic options.
Orthofix Medical Inc. is a worldwide medical system firm centered on musculoskeletal merchandise and therapies. The Firm’s mission is to enhance sufferers’ lives by offering superior reconstruction and regenerative musculoskeletal options to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s backbone and orthopedic extremities merchandise are distributed in additional than 70 international locations through the Firm’s gross sales representatives and distributors. For extra info, please go to www.orthofix.com.
Ahead Wanting Statements
This communication accommodates sure forward-looking statements beneath the Non-public Securities Litigation Reform Act of 1995. These forward-looking statements, which can embrace, however will not be restricted to, statements in regards to the estimates, projections, monetary situation, outcomes of operations and companies of Orthofix and its subsidiaries, are primarily based on Orthofix administration’s present expectations and estimates and contain dangers and uncertainties that would trigger precise outcomes or outcomes to vary materially from these contemplated by the forward-looking statements.
The forward-looking statements on this launch don’t represent ensures or guarantees of future efficiency. Components that would trigger or contribute to such variations might embrace, however will not be restricted to, dangers regarding: practices of medical health insurance corporations and different third-party payors with respect to reimbursement for our units and different dangers described within the “Danger Components” part of our 2019 Annual Report on Type 10-Okay, in addition to in different reviews that we file sooner or later. Current and potential traders are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date hereof. The Firm undertakes no obligation to replace or revise the knowledge contained on this press launch.
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CONTACT: Mark Fast
Tel 214 937 2924
email@example.com Denise Landry
Tel 214 937 2529
KEYWORD: UNITED STATES NORTH AMERICA TEXAS
INDUSTRY KEYWORD: HEALTH FDA MEDICAL DEVICES CONSUMER SURGERY PARENTING CHILDREN
SOURCE: Orthofix Medical Inc.
Copyright Enterprise Wire 2020.
PUB: 07/20/2020 07:00 AM/DISC: 07/20/2020 07:01 AM
Copyright Enterprise Wire 2020.