OrthoPediatrics Corp. · Class II · Cleared Apr 30, 2026
| K-number | K260323 |
| Device name | OrthoPediatrics® Locking Cannulated Blade Plate System |
| Applicant | OrthoPediatrics Corp. |
| Product code | HRS |
| Device class | Class II |
| Decision date | Apr 30, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The OrthoPediatrics Locking Cannulated Blade Plate System is a bone fixation device intended for surgical correction and fracture treatment in pediatric patients (except neonates) and small-stature adults. It combines osteotomy blade plates with cannulated instruments to fix long bone fractures and perform osteotomies at multiple anatomical sites including the hip, femur, tibia, and humerus.
The subject device shares identical intended use, patient population, and principles of operation with the predicate. Key differences are sterilization method (sterile vs. non-sterile packaging), packaging design, shelf life extension, and MR conditional labeling. Implants are manufactured from implant-grade stainless steel (ASTM F138) and include locking and non-locking cortical screws in 3.5 mm and 4.5 mm diameters, offered in three size ranges (infant, child, adolescent).
Sterilization and cleaning validation per AAMI ST72, ST98, ASTM F3127, ISO 11137-1/2, ISO 11737-1/2/3, ISO 19227; package design per ASTM D4332, D4169, F2096, F2203, F88, F1886, ISO 11607-1/2, ISO 15415/15416; shelf life per ASTM F1980, F1886, F2096, F2203, F88; usability per ISO 11607-1, IEC-62366-1; MR safety per ASTM F2052, F2213, F2182, F2119.
View the full FDA submission: accessdata.fda.gov