Cleared Special

K190321 - Pediatric Nailing PlatformFemur

K190321 is an FDA 510(k) clearance for Pediatric Nailing PlatformFemur, manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 238-day FDA review.

K190321 · OrthoPediatrics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
238d
Days
Class 2
Risk

K190321 is an FDA 510(k) clearance for the Pediatric Nailing PlatformFemur. 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 October 9, 2019 after a review of 238 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190321

510(k) Number K190321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2019
Decision Date October 09, 2019
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Modification to existing cleared device.

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 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K190321.
TTC Phantom® Intramedullary Nail System
K192163 · Paragon 28, Inc. · Jan 2020
EBA One Nailing System
K183666 · Citieffe S.R.L. · Nov 2019
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · Zimmer GmbH · Oct 2019
PRECICE System
K191336 · Nuvasive Specialized Orthopedics, Inc. · Sep 2019
TTC Phantom Intramedullary Nail System
K191782 · Paragon 28, Inc. · Sep 2019
Syntec Tibial Nail System
K191617 · Syntec Scientific Corporation · Sep 2019
K190321 · Pediatric Nailing PlatformFemur
Download PDF FDA Summary OrthoPediatrics Corp.