Cleared Traditional

METAGEN ALL POLY ACETABULAR CUP SYSTEM (K964003) - FDA 510(k) Clearance

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

K964003 · Metagen, LLC · Orthopedic device
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Mar 1997
Decision
165d
Days
Class 2
Risk

K964003 is an FDA 510(k) clearance for the METAGEN ALL POLY ACETABULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Metagen, LLC (Menomonie, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 165 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Metagen, LLC devices

Submission Details

510(k) Number K964003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date March 21, 1997
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K964003.
RECOVERY PROTRUSIO CAGE
K971890 · Biomet, Inc. · Aug 1997
DURATION STABILIZED UHMWPE
K963612 · Howmedica Corp. · Jun 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · Johnson & Johnson Professionals, Inc. · Feb 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · Howmedica Corp. · Feb 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · Osteonics Corp. · Feb 1997