Cleared Traditional

AMK FIXED STEM CEMENTED TIBIAL TRAY (K922620) - FDA 510(k) Clearance

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

K922620 · Depuy, Inc. · Orthopedic device
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Sep 1992
Decision
92d
Days
Class 2
Risk

K922620 is an FDA 510(k) clearance for the AMK FIXED STEM CEMENTED TIBIAL TRAY. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 3, 1992 after a review of 92 days - within the typical 510(k) review window.

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 Depuy, Inc. devices

Submission Details

510(k) Number K922620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date September 03, 1992
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 122d · This submission: 92d
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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K922620.
AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY
K923451 · Depuy, Inc. · Oct 1992
KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT
K921640 · Howmedica Corp. · Sep 1992
DURACON ALL PLASTIC TIBIAL COMPONENT
K922048 · Howmedica Corp. · 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