Cleared Special

GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD (K992065) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992065 · DePuy Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 1999
Decision
24d
Days
Class 2
Risk

K992065 is an FDA 510(k) clearance for the GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE EC.... Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K992065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date July 12, 1999
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 91
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K992065.
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · DePuy Orthopaedics, Inc. · Mar 2000
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · Biomet, Inc. · Oct 1999
BIO-MODULAR SHOULDER SYSTEM
K992119 · Biomet, Inc. · Sep 1999
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · Howmedica Osteonics Corp. · Mar 1999
DEPUY GLOBAL SHOULDER GLENOID
K981487 · DePuy Orthopaedics, Inc. · Jul 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · DePuy Orthopaedics, Inc. · Jan 1998