Cleared Traditional

K220679 - Pediatric Nailing Platform Femur

K220679 is an FDA 510(k) clearance for Pediatric Nailing Platform Femur, manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K220679 · OrthoPediatrics Corp. · Orthopedic device
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Jul 2022
Decision
134d
Days
Class 2
Risk

K220679 is an FDA 510(k) clearance for the 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 July 20, 2022 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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

FDA 510(k) Submission Details - K220679

510(k) Number K220679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2022
Decision Date July 20, 2022
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K220679.
Smith & Nephew Intramedullary Nail Systems
K210980 · Smith & Nephew, Inc. · Nov 2022
Artemis Proximal Femoral Nail System
K221489 · Glw, Inc. · Oct 2022
AUTOBAHN(R) EVO Femoral Nails
K220659 · Globus Medical, Inc. · Sep 2022
Flow-Nail
K221115 · Flow-Fx, LLC · May 2022
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
K213328 · Stryker GmbH · Feb 2022
GPC Intraheal Intramedullary Nailing System
K203811 · Gpc Medical Limited · Feb 2022