Cleared Traditional

K910992 - AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCE...

K910992 is the FDA 510(k) clearance for AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCE... by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 522-day FDA review.

K910992 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
522d
Days
Class 2
Risk

K910992 is an FDA 510(k) clearance for the AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE. 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 August 10, 1992 after a review of 522 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Depuy, Inc. devices

Submission Details

510(k) Number K910992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date August 10, 1992
Days to Decision 522 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
400d slower than avg
Panel avg: 122d · This submission: 522d
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 786
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K910992.
CONTINUUM KNEE SYSTEM
K920080 · Techmedica, Inc. · 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
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM
K920396 · Kirschner Medical Corp. · Aug 1992
PSK FEMORAL AND TIBIAL INSERT COMPONENT
K920426 · Orthomet, Inc. · Aug 1992
FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS
K920698 · Orthomet, Inc. · Aug 1992