Cleared Traditional

K071790 - GENESIS II TOTAL KNEE SYSTEM

K071790 is the FDA 510(k) clearance for GENESIS II TOTAL KNEE SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K071790 · Smith & Nephew, Inc. · Orthopedic device
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Aug 2007
Decision
46d
Days
Class 2
Risk

K071790 is an FDA 510(k) clearance for the GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE S.... Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K071790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date August 17, 2007
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 123
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K071790.
LEGION POROUS PRIMARY
K073325 · Smith & Nephew, Inc. · Dec 2007
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
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NEXGEN TRABECULAR METAL TIBIAL TRAY
K072160 · Zimmer, Inc. · Sep 2007
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
K071417 · DePuy Orthopaedics, Inc. · Aug 2007
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K071107 · Zimmer, Inc. · Jul 2007
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K070883 · Howmedica Osteonics Corp. · May 2007