Cleared Traditional

AMK LANDMARK REVISION KNEE SYSTEM (K925072) - FDA 510(k) Clearance

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

K925072 · Depuy, Inc. · Orthopedic device
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Jan 1994
Decision
471d
Days
Class 2
Risk

K925072 is an FDA 510(k) clearance for the AMK LANDMARK REVISION KNEE 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 January 21, 1994 after a review of 471 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 K925072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date January 21, 1994
Days to Decision 471 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
349d slower than avg
Panel avg: 122d · This submission: 471d
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 K925072.
THICK TIBIAL INSERT
K933289 · Wrightmedicaltechnologyinc · Aug 1994
HOWMEDICAL TOTAL KNEE STEM EXTENDER
K924482 · Howmedica Corp. · Feb 1994
DURACON CRUCIFORM TIBIAL BASEPLATE
K926228 · Howmedica Corp. · Feb 1994
AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY
K925837 · Depuy, Inc. · Jan 1994
MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS
K930831 · Zimmer, Inc. · Nov 1993
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K933304 · Depuy, Inc. · Aug 1993