Cleared Traditional

K171293 - G3 Active Plate Miniature System

K171293 is an FDA 510(k) clearance for G3 Active Plate Miniature System, manufactured by Genesis Fracture Care, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K171293 · Genesis Fracture Care, Inc. · Orthopedic device
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Oct 2017
Decision
174d
Days
Class 2
Risk

K171293 is an FDA 510(k) clearance for the G3™ Active Plate® Miniature System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Genesis Fracture Care, Inc. (Clackamas, US). The FDA issued a Cleared decision on October 23, 2017 after a review of 174 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Genesis Fracture Care, Inc. devices

FDA 510(k) Submission Details - K171293

510(k) Number K171293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2017
Decision Date October 23, 2017
Days to Decision 174 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1034
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K171293.
CoLink View Plating System
K172300 · In2bones USA, LLC · Nov 2017
ANTHEM Fracture System
K173166 · Globus Medical, Inc. · Nov 2017
Omni Foot Plating System
K172260 · Extremity Medical, LLC · Nov 2017
ARIX Wrist System
K170705 · Jeil Medical Corporation · Sep 2017
DARCO Locking Bone Plate System
K171852 · Wrightmedicaltechnologyinc · Sep 2017
Footmotion Plating System
K171510 · Newclip Technics · Sep 2017