Cleared Traditional

K042093 - VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS

K042093 is an FDA 510(k) clearance for VANGUARD M SERIES UNICONDYLAR TIBIAL BE..., manufactured by Biomet, 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.

K042093 · Biomet, Inc. · Orthopedic device
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Nov 2004
Decision
90d
Days
Class 2
Risk

K042093 is an FDA 510(k) clearance for the VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS. 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 November 1, 2004 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K042093

510(k) Number K042093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2004
Decision Date November 01, 2004
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 84
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K042093.
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · Biomet Manufacturing, Inc. · Jan 2006
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
K051721 · Global Orthopaedic Technology, USA, Inc. · Oct 2005
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764 · Corin USA · Aug 2005
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