Cleared Traditional

K173255 - Talon DistalFix Humeral Nail

K173255 is an FDA 510(k) clearance for Talon DistalFix Humeral Nail, manufactured by Orthopedic Designs North America, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K173255 · Orthopedic Designs North America, Inc. · Orthopedic device
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Feb 2018
Decision
135d
Days
Class 2
Risk

K173255 is an FDA 510(k) clearance for the Talon DistalFix Humeral Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthopedic Designs North America, Inc. (Tampa, US). The FDA issued a Cleared decision on February 22, 2018 after a review of 135 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 Orthopedic Designs North America, Inc. devices

FDA 510(k) Submission Details - K173255

510(k) Number K173255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2017
Decision Date February 22, 2018
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 366
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K173255.
Agile Nail
K172699 · Orthofix Srl · Apr 2018
PRECICE STRYDE System
K180503 · Nuvasive Specialized Orthopedics, Inc. · Apr 2018
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
K173811 · In2bones Sas · Mar 2018
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
K172189 · Truemed Group, LLC · Jan 2018
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
K172774 · Stryker Trauma GmbH · Jan 2018
AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017