Cleared Special

K020264 - REPICCI II UNICONDYLAR KNEE SYSTEM

K020264 is an FDA 510(k) clearance for REPICCI II UNICONDYLAR KNEE SYSTEM, manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Special 510(k) pathway after a 14-day FDA review.

K020264 · Biomet Orthopedics, Inc. · Orthopedic device
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Feb 2002
Decision
14d
Days
Class 2
Risk

K020264 is an FDA 510(k) clearance for the REPICCI II UNICONDYLAR KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet Orthopedics, Inc. devices

FDA 510(k) Submission Details - K020264

510(k) Number K020264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2002
Decision Date February 08, 2002
Days to Decision 14 days
Submission Type Special
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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K020264.
FIXED BEARING UNI COMPONENT
K021621 · Biomet, Inc. · Jun 2002
UNICONDYLAR KNEE
K020741 · Encore Orthopedics, Inc. · Jun 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · Wrightmedicaltechnologyinc · Mar 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · Wrightmedicaltechnologyinc · Nov 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · Biomet, Inc. · Jul 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · Biomet, Inc. · Jun 2001