Cleared Traditional

MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR (K895639) - FDA 510(k) Clearance

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

K895639 · Zimmer, Inc. · Orthopedic device
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Feb 1990
Decision
142d
Days
Class 2
Risk

K895639 is an FDA 510(k) clearance for the MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 8, 1990 after a review of 142 days - within the typical 510(k) review window.

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 Zimmer, Inc. devices

Submission Details

510(k) Number K895639 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 19, 1989
Decision Date February 08, 1990
Days to Decision 142 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K895639.
PCA (R) TIBIAL BONE WEDGES
K904170 · Howmedica Corp. · Oct 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · Depuy, Inc. · Aug 1990
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K901406 · Depuy, Inc. · Jul 1990
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
K894403 · Howmedica Corp. · Feb 1990
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · Johnson & Johnson Professionals, Inc. · Jan 1990
KINEMAX TIBIAL STEM EXTENSION
K896452 · Howmedica Corp. · Jan 1990