Cleared Traditional

K792240 - POLYCENTRIC TOTAL KNEE METAL TIBIAL

K792240 is the FDA 510(k) clearance for POLYCENTRIC TOTAL KNEE METAL TIBIAL by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K792240 · Howmedica Corp. · Orthopedic device
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Dec 1979
Decision
28d
Days
Class 2
Risk

K792240 is an FDA 510(k) clearance for the POLYCENTRIC TOTAL KNEE METAL TIBIAL. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1979 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 K792240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1979
Decision Date December 05, 1979
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 98
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K792240.
KENNEDY TIBIAL COMPONENT
K831513 · Biomet, Inc. · Jul 1983
GEO-TIBIAL RETAINER ROTATIONAL
K803235 · Zimmer, Inc. · Feb 1981
MEDICAL COMPARTMENT KNEE PROSTHESIS
K800640 · Dow Corning Wright · Apr 1980
TOTAL KNEE PROSTHESIS-NONCONSTRAINED
K771511 · 3M Company · Nov 1977