Cleared Traditional

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED (K901406) - FDA 510(k) Clearance

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

K901406 · Depuy, Inc. · Orthopedic device
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Jul 1990
Decision
119d
Days
Class 2
Risk

K901406 is an FDA 510(k) clearance for the ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED. 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 July 23, 1990 after a review of 119 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 K901406 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 26, 1990
Decision Date July 23, 1990
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 K901406.
AMK MODULAR TIBIAL WEDGE SYSTEM
K904205 · Depuy, Inc. · Oct 1990
PCA (R) TIBIAL BONE WEDGES
K904170 · Howmedica Corp. · Oct 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · Depuy, Inc. · Aug 1990
MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR
K895639 · Zimmer, Inc. · Feb 1990
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
K894403 · Howmedica Corp. · Feb 1990
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · Johnson & Johnson Professionals, Inc. · Jan 1990