Cleared Traditional

K920034 - DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC

K920034 is an FDA 510(k) clearance for DURACON MODULAR FEMORAL COMPONENT AND F..., manufactured by Pfizer Hospital Products Group, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K920034 · Pfizer Hospital Products Group, Inc. · Orthopedic device
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Mar 1992
Decision
72d
Days
Class 2
Risk

K920034 is an FDA 510(k) clearance for the DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC. 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 March 18, 1992 after a review of 72 days - a notably fast clearance 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: 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 Pfizer Hospital Products Group, Inc. devices

FDA 510(k) Submission Details - K920034

510(k) Number K920034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date March 18, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
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 907
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K920034.
FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS
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CONTINUUM KNEE SYSTEM (CKS)
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7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
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7000 SERIES MODULAR TIBIAL COMPONENTS
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