Cleared Traditional

K162898 - Olecranon Plating System

K162898 is the FDA 510(k) clearance for Olecranon 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 151-day FDA review.

K162898 · Miami Device Solutions, LLC · Orthopedic device
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Mar 2017
Decision
151d
Days
Class 2
Risk

K162898 is an FDA 510(k) clearance for the Olecranon 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 March 17, 2017 after a review of 151 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 Miami Device Solutions, LLC devices

Submission Details

510(k) Number K162898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date March 17, 2017
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 K162898.
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
K163650 · Wrightmedicaltechnologyinc · Apr 2017
EVOS Small Fragment Plating System
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ANTHEM™ Fracture System
K163361 · Globus Medical, Inc. · Apr 2017
ORTHOLOC® 3Di Small Bones Plating
K163039 · Wrightmedicaltechnologyinc · Mar 2017
Level One Hand Plating System
K170124 · KLS-Martin L.P. · Mar 2017
VariAx Distal Radius Plating System, VariAx 2 System
K162841 · Stryker GmbH · Feb 2017