Cleared Traditional

U2 TOTAL KNEE SYSTEM (K051640) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051640 · United Orthopedic Corp. · Orthopedic device
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Mar 2006
Decision
254d
Days
Class 2
Risk

K051640 is an FDA 510(k) clearance for the U2 TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by United Orthopedic Corp. (Hsinchu, TW). The FDA issued a Cleared decision on March 1, 2006 after a review of 254 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 United Orthopedic Corp. devices

Submission Details

510(k) Number K051640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2005
Decision Date March 01, 2006
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 517
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K051640.
LEGION COBALT CHROME REVISION KNEE SYSTEM
K060742 · Smith & Nephew, Inc. · May 2006
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
K060370 · Zimmer, Inc. · Apr 2006
DEPUY PFC SIGMA KNEE PROSTHESIS
K060515 · DePuy Orthopaedics, Inc. · Mar 2006
COLUMBUS (CR) TOTAL KNEE SYSTEM
K053390 · Aesculap, Inc. · Feb 2006
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
K052879 · Zimmer, Inc. · Nov 2005
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
K051977 · Howmedica Osteonics Corp. · Oct 2005