Cleared Traditional

K243963 - Pediatric Plating Platform Hip

K243963 is the FDA 510(k) clearance for Pediatric Plating Platform Hip by OrthoPediatrics Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K243963 · OrthoPediatrics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
127d
Days
Class 2
Risk

K243963 is an FDA 510(k) clearance for the Pediatric Plating Platform Hip. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on April 29, 2025 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all OrthoPediatrics Corp. devices

Submission Details

510(k) Number K243963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date April 29, 2025
Days to Decision 127 days
Submission Type Traditional
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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K243963.
ARIX Pectus Bar System
K242751 · Jeil Medical Corporation · May 2025
SIGNEX
K243469 · Osteonic Co., Ltd. · May 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate)
K250935 · TriMed, Inc. · May 2025
CastleLoc Pectus Bar System
K250892 · L & K Biomed Co., Ltd. · Apr 2025
CanMINI Hand and Foot System
K242973 · Canwell Medical Co., Ltd. · Apr 2025
Xpert Knee
K250155 · Newclip Technics · Apr 2025