Cleared Traditional

K020741 - UNICONDYLAR KNEE

K020741 is an FDA 510(k) clearance for UNICONDYLAR KNEE, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020741 · Encore Orthopedics, Inc. · Orthopedic device
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Jun 2002
Decision
90d
Days
Class 2
Risk

K020741 is an FDA 510(k) clearance for the UNICONDYLAR KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 4, 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 888.3530 - 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K020741

510(k) Number K020741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date June 04, 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.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K020741.
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193 · Wrightmedicaltechnologyinc · Feb 2003
UNI KNEE
K022437 · Encore Medical, L.P. · Aug 2002
FIXED BEARING UNI COMPONENT
K021621 · Biomet, Inc. · Jun 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · Wrightmedicaltechnologyinc · Mar 2002
REPICCI II UNICONDYLAR KNEE SYSTEM
K020264 · Biomet Orthopedics, Inc. · Feb 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · Wrightmedicaltechnologyinc · Nov 2001