Cleared Traditional

DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS (K915512) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915512 · Pfizer Hospital Products Group, Inc. · Orthopedic device
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Aug 1992
Decision
253d
Days
Class 2
Risk

K915512 is an FDA 510(k) clearance for the DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Pfizer Hospital Products Group, Inc. (Rutherford, US). The FDA issued a Cleared decision on August 18, 1992 after a review of 253 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 Pfizer Hospital Products Group, Inc. devices

Submission Details

510(k) Number K915512 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 09, 1991
Decision Date August 18, 1992
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 122d · This submission: 253d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K915512.
KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT
K921640 · Howmedica Corp. · Sep 1992
DURACON ALL PLASTIC TIBIAL COMPONENT
K922048 · Howmedica Corp. · Sep 1992
AMK FIXED STEM CEMENTED TIBIAL TRAY
K922620 · Depuy, Inc. · Sep 1992
AGC AND MAXIM KNEE COMPONENTS WITH NTS
K922285 · Biomet, Inc. · Aug 1992
7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA
K922104 · Osteonics Corp. · Aug 1992
AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE
K910992 · Depuy, Inc. · Aug 1992