Cleared Traditional

K163039 - ORTHOLOC® 3Di Small Bones Plating

K163039 is an FDA 510(k) clearance for ORTHOLOC 3Di Small Bones Plating, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K163039 · Wrightmedicaltechnologyinc · Orthopedic device
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Mar 2017
Decision
133d
Days
Class 2
Risk

K163039 is an FDA 510(k) clearance for the ORTHOLOC® 3Di Small Bones Plating. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on March 13, 2017 after a review of 133 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K163039

510(k) Number K163039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date March 13, 2017
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K163039.
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
K163425 · Narang Medical USA Corporation · Mar 2017
Olecranon Plating System
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Y3 Proximal Femoral Plate System
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Level One Hand Plating System
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AlignMATE™ Lapidus Arthrodesis System
K162391 · Arthrosurface, Inc. · Feb 2017
VariAx Distal Radius Plating System, VariAx 2 System
K162841 · Stryker GmbH · Feb 2017