Cleared Traditional

K172774 - T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

K172774 is an FDA 510(k) clearance for T2 Alpha Femur Antegrade GT/PF Nailing ..., manufactured by Stryker Trauma GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K172774 · Stryker Trauma GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
120d
Days
Class 2
Risk

K172774 is an FDA 510(k) clearance for the T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instrum.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker Trauma GmbH (Schoenkirchen, DE). The FDA issued a Cleared decision on January 12, 2018 after a review of 120 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 Stryker Trauma GmbH devices

FDA 510(k) Submission Details - K172774

510(k) Number K172774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2017
Decision Date January 12, 2018
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 K172774.
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
K173811 · In2bones Sas · Mar 2018
Talon DistalFix Humeral Nail
K173255 · Orthopedic Designs North America, Inc. · Feb 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
AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017
Piccolo Composite Nailing System
K173652 · CarboFix Orthopedics , Ltd. · Dec 2017
Apex Tibial Nailing System
K170972 · Orthoxel · Dec 2017