OrthoPediatrics Announces FDA 510(k) Clearance of PNP | Femur Retrograde Nail System and Completes First Implantations

Availability will remain limited for the remainder of 2026, with broader commercialization planned for 2027.

Rhea-AI Summary

OrthoPediatrics (Nasdaq: KIDS) received FDA 510(k) clearance for its PNP Femur Retrograde Nail System and completed the first procedures using it.

The system adds a pediatric femoral trauma and deformity-correction option to the Pediatric Nailing Platform, using existing platform instrumentation. It includes anatomic nails for trauma and straight nails for deformity. Availability will be through a limited market release for the remainder of 2026, with broader commercialization planned for 2027.

Positive

• Minor pointFDA 510(k) clearance adds PNP Retrograde to the pediatric orthopedic portfolio.
• Minor pointFirst procedures completed using the PNP Femur Retrograde Nail System.
• Minor point. Forward-looking: it has not happened yet and may not happen.Broader commercialization planned for 2027 following the limited market release.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Limited market release restricts system availability for the remainder of 2026.

Key Figures

Limited market release: Remainder of 2026 Broader commercialization: 2027 Nail diameter range: 7 mm to 11 mm

Limited market release

Remainder of 2026

Planned availability

Broader commercialization

2027

Planned timing

Nail diameter range

7 mm to 11 mm

Both nail designs

Key Terms

510(k), varus/valgus, coronal/sagittal plane

3 terms

510(k) regulatory

"FDA 510(k) Clearance of PNP"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

varus/valgus medical

"complex varus/valgus and coronal/sagittal plane correction procedures"

Describes the direction of an angular deformity at a joint: varus means the bone or limb segment distal to the joint is angled toward the body's midline (medial deviation); valgus means the distal segment is angled away from the midline (lateral deviation). The terms are used to describe alignment of bones, joints, fractures, or orthopaedic implants (for example, varus/valgus alignment of the knee or hip) and always refer to the direction of the distal segment relative to the proximal segment.

coronal/sagittal plane medical

"coronal/sagittal plane correction procedures"

Two standard anatomical planes used to describe locations and images of the body: the coronal plane is a vertical slice that divides the body into front (anterior) and back (posterior) portions, producing a frontal view; the sagittal plane is a vertical slice that divides the body into left and right portions, with the midsagittal (or median) plane running exactly down the middle and parasagittal planes offset from the midline. In medical imaging and anatomy, these planes specify the direction of the view or cut — coronal for front-to-back perspective and sagittal for side-to-side perspective — and do not imply thickness or specific imaging modality.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

New addition to the Pediatric Nailing Platform expands options for pediatric femoral trauma and deformity correction

WARSAW, Ind., Oct. 27, 2026 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. ("OrthoPediatrics" or the "Company") (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced U.S. Food and Drug Administration (FDA) clearance of the Pediatric Nailing Platform (PNP) | Femur Retrograde Nail System (“PNP Retrograde”) and the successful completion of the first procedures using the system.

Developed in collaboration with a team of pediatric orthopedic surgeons, the system was designed specifically for pediatric anatomy to address an important unmet market need and includes anatomic nails for trauma and straight nails for deformity. PNP Retrograde builds on the Company's successful previous launches of PNP Femur and PNP Tibia and leverages existing PNP instrumentation. The new system offers innovative instruments intended to help simplify complex varus/valgus and coronal/sagittal plane correction procedures.

"Our Pediatric Nailing Platform has supported nearly 15,000 patients worldwide, demonstrating the impact of our differentiated approach to pediatric orthopedic care," said Joe Hauser. "The FDA clearance of PNP Retrograde expands our portfolio and creates an opportunity to reach more children with implants designed specifically for their needs. With the first surgical case already complete, we are encouraged by the initial adoption of this latest addition to our platform. By addressing the unique anatomical needs of growing children that adult-focused systems may not fully accommodate, we continue to strengthen OrthoPediatrics’ position as a leader in pediatric-specific orthopedic solutions."

PNP Retrograde is available in diameters ranging from 7 mm to 11 mm in both nail designs. The system will be available through a limited market release for the remainder of 2026, with broader commercialization planned for 2027.

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 over 95 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 75 countries outside the United States. For more information, please visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.

Investor Contact
Philip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Has OrthoPediatrics received FDA clearance for PNP Retrograde and begun using it?

OrthoPediatrics has received FDA 510(k) clearance for the PNP Femur Retrograde Nail System and completed the first procedures using it.

When will OrthoPediatrics broadly commercialize PNP Retrograde?

Broader commercialization is planned for 2027. The system will be available through a limited market release for the remainder of 2026.