Cleared Traditional

K901406 - ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED

K901406 is an FDA 510(k) clearance for ANATOMIC MODULAR KNEE (AMK) POSTERIOR S..., 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 119-day FDA review.

K901406 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K901406

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.

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 K901406.
DORR KNEE SYSTEM
K901085 · Intermedics Orthopedics · Sep 1990
NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)
K902335 · Intermedics Orthopedics · Aug 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · Depuy, Inc. · Aug 1990
SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR
K895145 · Orthomet, Inc. · Jul 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · Orthomet, Inc. · Jul 1990
WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM
K901992 · Dow Corning Wright · Jun 1990