Cleared Traditional

NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS (K031061) - FDA 510(k) Clearance

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

K031061 · Zimmer, Inc. · Orthopedic device
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Oct 2003
Decision
189d
Days
Class 2
Risk

K031061 is an FDA 510(k) clearance for the NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 189 days - an extended review 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: 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 Zimmer, Inc. devices

Submission Details

510(k) Number K031061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date October 09, 2003
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 106
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K031061.
SCORPIO TOTAL KNEE SYSTEM
K033972 · Howmedica Osteonics Corp. · Apr 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108 · Aesculap, Inc. · Jan 2004
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · Smith & Nephew, Inc. · Oct 2003
DURACON TOTAL KNEE SYSTEM
K032163 · Howmedica Osteonics Corp. · Sep 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · Howmedica Osteonics Corp. · Sep 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · Smith & Nephew, Inc. · May 2003