Cleared Traditional

K792089 - THE HOWMEDICA KINEMATIC KNEE SYSTEM

K792089 is an FDA 510(k) clearance for THE HOWMEDICA KINEMATIC KNEE SYSTEM, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K792089

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.

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 885
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