Cleared Traditional

K162124 - Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins

K162124 is an FDA 510(k) clearance for Synthes 4.5mm VA-LCP Curved Condylar Pl..., manufactured by DePuy Synthes. The device is a Class 2 Orthopedic device with product code JDP cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K162124 · DePuy Synthes · Orthopedic device
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Mar 2017
Decision
240d
Days
Class 2
Risk

K162124 is an FDA 510(k) clearance for the Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable An.... Classified as Condylar Plate Fixation Implant (product code JDP), Class II - Special Controls.

Submitted by DePuy Synthes (West Chester, US). The FDA issued a Cleared decision on March 29, 2017 after a review of 240 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 DePuy Synthes devices

FDA 510(k) Submission Details - K162124

510(k) Number K162124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date March 29, 2017
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDP Device Classification - Class 2, Special Controls

Product Code JDP Condylar Plate Fixation Implant
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.