DeviceClearance

OrthoPediatrics® Locking Cannulated Blade Plate System— 510(k) K260323

Substantially Equivalent

OrthoPediatrics Corp.

FDA 510(k) clearance K260323 for OrthoPediatrics® Locking Cannulated Blade Plate System, Substantially Equivalent on 2026-04-30. Applicant: OrthoPediatrics Corp.. Device class: 2.

Summary

OrthoPediatrics' Locking Cannulated Blade Plate System is filed under product code HRS (Plate, Fixation, Bone).

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

OrthoPediatrics filed from Warsaw, Indiana. The decision came 90 calendar days after FDA received it (January 30 to April 30, 2026).

Clearance details

Applicant
OrthoPediatrics Corp.
Product code
Product code HRS
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HRS

product code HRS
Death
27
Injury
10,340
Malfunction
3,328
Total
13,695

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.