Cleared Traditional

K051640 - U2 TOTAL KNEE SYSTEM

K051640 is an FDA 510(k) clearance for U2 TOTAL KNEE SYSTEM, manufactured by United Orthopedic Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K051640 · United Orthopedic Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K051640

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
Combination Product No
PCCP Authorized No
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.

JWH Device Classification - Class 2, Special Controls

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 836
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K051640.
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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
TRIATHLON TOTAL KNEE SYSTEM
K053514 · Stryker Orthopaedics · Jan 2006
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
K052879 · Zimmer, Inc. · Nov 2005