Cleared Traditional

K911572 - MG II POROUS COBAL T-CHROME FEMORAL COM...

K911572 is an FDA 510(k) clearance for MG II POROUS COBAL T-CHROME FEMORAL COM..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K911572 · Zimmer, Inc. · Orthopedic device
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Jul 1991
Decision
84d
Days
Class 2
Risk

K911572 is an FDA 510(k) clearance for the MG II POROUS COBAL T-CHROME FEMORAL COMPONENT. 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 July 1, 1991 after a review of 84 days - a notably fast clearance cycle.

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: 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K911572

510(k) Number K911572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date July 01, 1991
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K911572.
AGC REVISION KNEE PROTHESIS
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TOWNLEY TOTAL KNEE (TTK)
K904448 · Biopro, Inc. · Jul 1991
PCA MTK II TOTAL KNEE SYSTEM
K910235 · Howmedica Corp. · Jun 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
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K905810 · Joint Medical Products Corp. · Jun 1991