Cleared Traditional

K923573 - DURACON METAL BACKED PATELLA

K923573 is the FDA 510(k) clearance for DURACON METAL BACKED PATELLA by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K923573 · Howmedica Corp. · Orthopedic device
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Mar 1993
Decision
242d
Days
Class 2
Risk

K923573 is an FDA 510(k) clearance for the DURACON METAL BACKED PATELLA. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 242 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 K923573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date March 16, 1993
Days to Decision 242 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 122d · This submission: 242d
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 765
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K923573.
WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP
K915525 · Dow Corning Wright · May 1993
NATURAL-KNEE ALL-POLY TIBIA
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KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER
K925901 · Howmedica Corp. · Mar 1993
OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP
K925372 · Osteonics Corp. · Feb 1993
FOUNDATION KNEE SYSTEM
K923277 · Encore Orthopedics, Inc. · Feb 1993
AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY
K923451 · Depuy, Inc. · Oct 1992