Cleared Traditional

K790219 - PROTHESIS

K790219 is an FDA 510(k) clearance for PROTHESIS, 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 98-day FDA review.

K790219 · Zimmer, Inc. · Orthopedic device
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May 1979
Decision
98d
Days
Class 2
Risk

K790219 is an FDA 510(k) clearance for the PROTHESIS, RETAINED GEOMETRIC KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1979 after a review of 98 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K790219

510(k) Number K790219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1979
Decision Date May 08, 1979
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 K790219.
POROCOAT TM TOWNLEY ANATOMIC KNEE
K810326 · Depuy, Inc. · Mar 1981
POROUS COATED ANATOMICAL-TOTAL KNEE
K802922 · Howmedica Corp. · Dec 1980
THE HOWMEDICA KINEMATIC KNEE SYSTEM
K792089 · Howmedica Corp. · May 1980
PROSTHESIS, KNEE, TOTAL
K781294 · Biomet, Inc. · Aug 1978
PATELLAR PROSTHESIS
K772225 · Cutter Laboratories, Inc. · Dec 1977
PATELLA PROSTHESIS/TRAIL COMPONENT
K771598 · Depuy, Inc. · Aug 1977