Cleared Special

K250623 - Pediatric Nailing Platform Tibia Pediat...

K250623 is the FDA 510(k) clearance for Pediatric Nailing Platform Tibia Pediat... by OrthoPediatrics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 29-day FDA review.

K250623 · OrthoPediatrics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
29d
Days
Class 2
Risk

K250623 is an FDA 510(k) clearance for the Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on April 1, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all OrthoPediatrics Corp. devices

Submission Details

510(k) Number K250623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2025
Decision Date April 01, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 318
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K250623.
GMReis Fibula Nail System
K250559 · Gm Dos Reis Industria E Comercio · Jun 2025
ARIX Femur Nail System
K242247 · Jeil Medical Corporation · Apr 2025
FitboneTM Trochanteric
K250112 · Orthofix Srl · Apr 2025
Fassier-Duval Telescoping IM System
K241983 · Orthopediatrics Canada Ulc Dba Pega Medical · Feb 2025
Affixus Tibial Nailing System - 4mm screws
K243907 · Zimmer, Inc. · Feb 2025
Arthrex Intramedullary Nails
K243890 · Arthrex, Inc. · Jan 2025