Cleared Special

NEXGEN TRABECULAR METAL TIBIAL TRAY (K072160) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072160 · Zimmer, Inc. · Orthopedic device
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Sep 2007
Decision
30d
Days
Class 2
Risk

K072160 is an FDA 510(k) clearance for the NEXGEN TRABECULAR METAL TIBIAL TRAY. 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 September 5, 2007 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K072160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date September 05, 2007
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K072160.
REGENEREX TIBIAL COMPONENTS
K080361 · Biomet, Inc. · Apr 2008
LEGION POROUS PRIMARY
K073325 · Smith & Nephew, Inc. · Dec 2007
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
K072619 · Zimmer, Inc. · Nov 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
K071790 · Smith & Nephew, Inc. · Aug 2007
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
K071417 · DePuy Orthopaedics, Inc. · Aug 2007
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K071107 · Zimmer, Inc. · Jul 2007