Cleared Traditional

AGILITY ANKLE REVISION PROSTHESIS (K020541) - FDA 510(k) Clearance

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

K020541 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
90d
Days
Class 2
Risk

K020541 is an FDA 510(k) clearance for the AGILITY ANKLE REVISION PROSTHESIS. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 20, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - 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 K020541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date May 20, 2002
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
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 - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 55
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K020541.
INBONE TOTAL ANKLE SYSTEM MODEL 200347902
K103374 · Wrightmedicaltechnologyinc · Dec 2010
INBONE II TOTAL ANKLE REPLACEMENT
K100886 · Wrightmedicaltechnologyinc · Aug 2010
AGILITY LP TOTAL ANKLE PROSTHESIS
K053569 · DePuy Orthopaedics, Inc. · Mar 2006
ALVINE TOTAL ANKLE
K920802 · Depuy, Inc. · Dec 1992
BRIGHAM TOTAL ANKLE PROSTHESIS
K803167 · Howmedica Corp. · Feb 1981
FORCEPS, ANKLE INSERTING, CON-AXIAL
K770420 · Depuy, Inc. · Mar 1977