Cleared Traditional

K161292 - Distal Radius Plating System

K161292 is the FDA 510(k) clearance for Distal Radius Plating System by Miami Device Solutions, LLC. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K161292 · Miami Device Solutions, LLC · Orthopedic device
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Aug 2016
Decision
98d
Days
Class 2
Risk

K161292 is an FDA 510(k) clearance for the Distal Radius Plating 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 Miami Device Solutions, LLC (Miami, US). The FDA issued a Cleared decision on August 15, 2016 after a review of 98 days - within the typical 510(k) review window.

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 Miami Device Solutions, LLC devices

Submission Details

510(k) Number K161292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2016
Decision Date August 15, 2016
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 886
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161292.
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ARIX Foot System
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AxSOS 3Ti
K153379 · Stryker GmbH · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016