Cleared Abbreviated

K030612 - GENESIS II TOTAL KNEE SYSTEM

K030612 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 Abbreviated 510(k) pathway after a 90-day FDA review.

K030612 · Smith & Nephew, Inc. · Orthopedic device
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May 2003
Decision
90d
Days
Class 2
Risk

K030612 is an FDA 510(k) clearance for the GENESIS II TOTAL KNEE SYSTEM. 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 May 27, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K030612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2003
Decision Date May 27, 2003
Days to Decision 90 days
Submission Type Abbreviated
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 K030612.
DURACON TOTAL KNEE SYSTEM
K032163 · Howmedica Osteonics Corp. · Sep 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · Howmedica Osteonics Corp. · Sep 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462 · Implex Corp. · Aug 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · Smith & Nephew, Inc. · May 2003