Cleared Traditional

K792089 - THE HOWMEDICA KINEMATIC KNEE SYSTEM

K792089 is the FDA 510(k) clearance for THE HOWMEDICA KINEMATIC KNEE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K792089 · Howmedica Corp. · Orthopedic device
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May 1980
Decision
202d
Days
Class 2
Risk

K792089 is an FDA 510(k) clearance for the THE HOWMEDICA KINEMATIC KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on May 6, 1980 after a review of 202 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 K792089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1979
Decision Date May 06, 1980
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
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 769
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K792089.
BIO CONDYLAR TM KNEE
K810328 · Depuy, Inc. · Apr 1981
POROCOAT TM TOWNLEY ANATOMIC KNEE
K810326 · Depuy, Inc. · Mar 1981
POROUS COATED ANATOMICAL-TOTAL KNEE
K802922 · Howmedica Corp. · Dec 1980
PROTHESIS, RETAINED GEOMETRIC KNEE
K790219 · Zimmer, Inc. · May 1979
PROSTHESIS, KNEE, TOTAL
K781294 · Biomet, Inc. · Aug 1978
PATELLAR PROSTHESIS
K772225 · Cutter Laboratories, Inc. · Dec 1977