Cleared Traditional

VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS (K060303) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060303 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
52d
Days
Class 2
Risk

K060303 is an FDA 510(k) clearance for the VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on March 30, 2006 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K060303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date March 30, 2006
Days to Decision 52 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 107
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K060303.
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
K062654 · DePuy Orthopaedics, Inc. · Sep 2006
ADVANCE TOTAL KNEE SYSTEM
K061223 · Wrightmedicaltechnologyinc · Aug 2006
TRIATHLON METAL BACKED PATELLA
K061521 · Howmedica Osteonics Corp. · Aug 2006
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
K051380 · Howmedica Osteonics Corp. · Aug 2005
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
K050222 · Biomet, Inc. · Aug 2005
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL
K043083 · Wrightmedicaltechnologyinc · Apr 2005