Cleared Traditional

K163046 - DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long

K163046 is an FDA 510(k) clearance for DePuy Synthes 2.4/2.7mm VA LCP Two-Colu..., manufactured by DePuy Synthes. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K163046 · DePuy Synthes · Orthopedic device
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Feb 2017
Decision
100d
Days
Class 2
Risk

K163046 is an FDA 510(k) clearance for the DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by DePuy Synthes (West Chester, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 100 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 DePuy Synthes devices

FDA 510(k) Submission Details - K163046

510(k) Number K163046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2016
Decision Date February 09, 2017
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 1214
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K163046.
AlignMATE™ Lapidus Arthrodesis System
K162391 · Arthrosurface, Inc. · Feb 2017
VariAx Distal Radius Plating System, VariAx 2 System
K162841 · Stryker GmbH · Feb 2017
APTUS® Coronoid 2.0
K161861 · Medartis AG · Feb 2017
AxSOS 3 Ti
K162439 · Stryker GmbH · Feb 2017
dynaMX™ Compression Plate
K161303 · Mx Orthopedics, Corp. · Jan 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044 · Wrightmedicaltechnologyinc · Jan 2017