Cleared Traditional

K823420 - KINEMATIC II KNEE SYSTEM

K823420 is the FDA 510(k) clearance for KINEMATIC II KNEE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KRO) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K823420 · Howmedica Corp. · Orthopedic device
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Feb 1983
Decision
84d
Days
Class 2
Risk

K823420 is an FDA 510(k) clearance for the KINEMATIC II KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1983 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K823420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date February 07, 1983
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 69
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K823420.
FINN KNEE SYSTEM
K945028 · Biomet, Inc. · Feb 1996
FINN KNEE PROSTHESIS
K910877 · Biomet, Inc. · Jul 1991
DCW MODULAR DISTAL FEMORAL SYSTEM
K910596 · Dow Corning Wright · May 1991
NATURALYTE BICARBONATE DIALYSATE 4400
K823115 · Erika, Inc. · Dec 1982
BARD ENDO LINK INTRACONDYLAR ROTATING
K821476 · C.R. Bard, Inc. · Jun 1982
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
K821340 · Intermedics Orthopedics · May 1982