Cleared Traditional

K964003 - METAGEN ALL POLY ACETABULAR CUP SYSTEM

K964003 is an FDA 510(k) clearance for METAGEN ALL POLY ACETABULAR CUP SYSTEM, manufactured by Metagen, LLC. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 165-day FDA review.

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

FDA 510(k) Submission Details - K964003

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
Combination Product No
PCCP Authorized No
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.

JDI Device Classification - Class 2, Special Controls

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 514
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K964003.
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K970194 · Stelkast Company · Apr 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · Corin USA · Mar 1997
GLOBAL TAPER SPECTRON HIP STEMS
K970351 · Smith & Nephew, Inc., Orthopaedic Div. · Feb 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