Cleared Traditional

K904208 - KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM

K904208 is the FDA 510(k) clearance for KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K904208 · Howmedica Corp. · Orthopedic device
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Apr 1991
Decision
201d
Days
Class 2
Risk

K904208 is an FDA 510(k) clearance for the KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 201 days - an extended review 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: 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 Howmedica Corp. devices

Submission Details

510(k) Number K904208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date April 01, 1991
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
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 768
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K904208.
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM
K911197 · Orthomet, Inc. · May 1991
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY
K911198 · Orthomet, Inc. · May 1991
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
K910500 · Howmedica Corp. · May 1991
WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT
K905076 · Dow Corning Wright · Feb 1991
AMK MODULAR TIBIAL WEDGE SYSTEM
K904205 · Depuy, Inc. · Oct 1990
PCA (R) TIBIAL BONE WEDGES
K904170 · Howmedica Corp. · Oct 1990