Cleared Traditional

K172583 - OrthoPediatrics PediNail Intramedullary Platform

K172583 is an FDA 510(k) clearance for OrthoPediatrics PediNail Intramedullary..., manufactured by Orthopediatrics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K172583 · Orthopediatrics, Inc. · Orthopedic device
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May 2018
Decision
255d
Days
Class 2
Risk

K172583 is an FDA 510(k) clearance for the OrthoPediatrics PediNail Intramedullary Platform. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthopediatrics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 10, 2018 after a review of 255 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. 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, Inc. devices

FDA 510(k) Submission Details - K172583

510(k) Number K172583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date May 10, 2018
Days to Decision 255 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
133d slower than avg
Panel avg: 122d · This submission: 255d
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 K172583.
Arthrex FibuLock Nail
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Apex Femoral Nailing System
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Agile Nail
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PRECICE STRYDE System
K180503 · Nuvasive Specialized Orthopedics, Inc. · Apr 2018
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
K173811 · In2bones Sas · Mar 2018