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The Tracker / September 2026 / K261345

510(k) cleared

Pediatric Nailing Platform Femur

OrthoPediatrics Corp. · Sep 24, 2026 · K261345

FDA cleared the Pediatric Nailing Platform Femur from OrthoPediatrics Corp. on Sep 24, 2026 under K261345, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 23, 2026. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

OrthoPediatrics Corp. has 2 other decisions in the tracker over the last 12 months: K260323 (OrthoPediatrics® Locking Cannulated Blade Plate System), K252600 (Pediatric Plating Platform I Small-Mini).

Questions & Answers

What did FDA clear under K261345?

K261345 is the FDA 510(k) for Pediatric Nailing Platform Femur, submitted by OrthoPediatrics Corp.. FDA's decision date was Sep 24, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Pediatric Nailing Platform Femur?

OrthoPediatrics Corp., based in Warsaw, IN, is the applicant of record for K261345.

How long did the K261345 review take?

FDA received the submission on Apr 23, 2026 and issued its decision on Sep 24, 2026, 154 days later.

← All decisions in September 2026

Sources