Cleared Traditional

K000575 - GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD

K000575 is an FDA 510(k) clearance for GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K000575 · DePuy Orthopaedics, Inc. · Orthopedic device
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Mar 2000
Decision
17d
Days
Class 2
Risk

K000575 is an FDA 510(k) clearance for the GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD. 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 March 10, 2000 after a review of 17 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. 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

FDA 510(k) Submission Details - K000575

510(k) Number K000575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date March 10, 2000
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

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 156
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K000575.
AEQUALIS UNIVERSAL SHOULDER GLENOID
K994393 · Tornier · Jun 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · Biopro, Inc. · Jun 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · Smith & Nephew, Inc. · May 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · Tornier · Mar 2000
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · Biomet, Inc. · Oct 1999
BIO-MODULAR SHOULDER SYSTEM
K992119 · Biomet, Inc. · Sep 1999