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OrthoPediatrics Corp. Launches Pediatric Nailing Platform | Tibia

Key Takeaway: OrthoPediatrics Corp. has launched its new Pediatric Nailing Platform TIBIA system aimed at treating pediatric patients with fractures and deformities. The system, which recently received FDA 510(k) clearance, is part of a broader product suite designed specifically for children's orthopedic needs. Successful initial cases have demonstrated its effectiveness for a diverse range of patients, reflecting the company's commitment to addressing pediatric orthopedic challenges.
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POSITIVE FACTORS

  • Launch of a new Pediatric Nailing Platform TIBIA system.
  • Successfully completed first cases during limited launch.
  • Received 510(k) clearance from the FDA.
  • Versatile design accommodates a wide range of pediatric patients.

Full Press Release Details

WARSAW, Ind., Oct. 19, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, announced today it has released the new Pediatric Nailing Platform TIBIA system and successfully completed the first cases in its limited launch. The Company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in September 2023.
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 52 unique systems designed specifically to help treat the needs of pediatric patients. 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.
The PNP Tibia system’s versatility and scope was on full display for these two surgical cases. One case was a trauma procedure for a 6’5” teenager who required a large nail (12mm X 420mm), while the other was a deformity correction procedure for a smaller stature 15-year-old where a 7mm X 285mm nail was used. These two cases reflect OP having the broadest scope of pediatric focused cannulated nails in the industry allowing surgeons to address kids of all sizes and needs.
Joe Hauser, President of OrthoPediatrics’ Trauma & Deformity Correction business stated, “It is extremely gratifying to see the system perform successfully in two unique and challenging cases. It shows the expert surgeon design team hit the mark along with OP engineers to design a system that will help many kids in the years to come”.
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 52 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.

Frequently Asked Questions

What is the new system introduced by OrthoPediatrics?

OrthoPediatrics launched the Pediatric Nailing Platform TIBIA system for treating lower extremity fractures and deformities.

When did OrthoPediatrics receive FDA clearance?

The FDA granted 510(k) clearance for the PNP Tibia system in September 2023.

How many systems does OrthoPediatrics offer?

OrthoPediatrics has 52 unique systems designed for pediatric orthopedic needs.

What sizes do the cannulated nails come in?

The PNP Tibia system features cannulated nails ranging from 7mm to 12mm in diameter.

Who can benefit from the PNP Tibia system?

The PNP Tibia system addresses the needs of pediatric patients of all sizes and requirements.

Last updated: Oct 19, 2023