Cleared Special

REPICCI LOCKED KEEL TIBIAL BEARING (K030446) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030446 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 50
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K030446.
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · Exactech, Inc. · Oct 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · DePuy Orthopaedics, Inc. · May 2004
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193 · Wrightmedicaltechnologyinc · Feb 2003
FIXED BEARING UNI COMPONENT
K021621 · Biomet, Inc. · Jun 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · Wrightmedicaltechnologyinc · Mar 2002