Cleared Traditional

K904205 - AMK MODULAR TIBIAL WEDGE SYSTEM

K904205 is an FDA 510(k) clearance for AMK MODULAR TIBIAL WEDGE SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K904205 · Depuy, Inc. · Orthopedic device
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Oct 1990
Decision
40d
Days
Class 2
Risk

K904205 is an FDA 510(k) clearance for the AMK MODULAR TIBIAL WEDGE SYSTEM. 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 October 22, 1990 after a review of 40 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K904205

510(k) Number K904205 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 12, 1990
Decision Date October 22, 1990
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
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 891
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K904205.
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WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT
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INSET PATELLAR COMPONENT
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K901085 · Intermedics Orthopedics · Sep 1990