Cleared Special

K030446 - REPICCI LOCKED KEEL TIBIAL BEARING

K030446 is the FDA 510(k) clearance for REPICCI LOCKED KEEL TIBIAL BEARING by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HRY) cleared through the Special 510(k) pathway after a 23-day FDA review.

K030446 · Biomet, Inc. · Orthopedic device
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Mar 2003
Decision
23d
Days
Class 2
Risk

K030446 is an FDA 510(k) clearance for the REPICCI LOCKED KEEL TIBIAL BEARING. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 23 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, Inc. devices

Submission Details

510(k) Number K030446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date March 06, 2003
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K030446.
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · Exactech, Inc. · Oct 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · DePuy Orthopaedics, Inc. · May 2004
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · Plus Orthopedics · Jul 2003
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