Cleared Traditional

GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT (K011047) - FDA 510(k) Clearance

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

K011047 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jun 2001
Decision
83d
Days
Class 2
Risk

K011047 is an FDA 510(k) clearance for the GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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 DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K011047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date June 28, 2001
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 28
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K011047.
BI-ANGULAR SHOULDER SYSTEM
K032895 · Biomet, Inc. · Nov 2003
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · Biomet, Inc. · Aug 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · DePuy Orthopaedics, Inc. · Jul 2001
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
K844415 · Depuy, Inc. · Jan 1985