Cleared Traditional

K915132 - MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM

K915132 is an FDA 510(k) clearance for MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915132 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
90d
Days
Class 2
Risk

K915132 is an FDA 510(k) clearance for the MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 11, 1992 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 888.3560 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K915132

510(k) Number K915132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date February 11, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
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
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 K915132.
CONTINUUM KNEE SYSTEM (CKS)
K914072 · Techmedica, Inc. · Feb 1992
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
K915186 · Osteonics Corp. · Feb 1992
7000 SERIES MODULAR TIBIAL COMPONENTS
K915192 · Osteonics Corp. · Feb 1992
WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP
K914169 · Dow Corning Wright · Jan 1992
KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM
K913492 · Kirschner Medical Corp. · Dec 1991
AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY
K914230 · Orthomet, Inc. · Dec 1991