Cleared Traditional

K914000 - GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE

K914000 is an FDA 510(k) clearance for GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHA..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K914000 · Depuy, Inc. · Orthopedic device
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Dec 1991
Decision
89d
Days
Class 2
Risk

K914000 is an FDA 510(k) clearance for the GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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, Inc. devices

FDA 510(k) Submission Details - K914000

510(k) Number K914000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date December 04, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 66
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K914000.
NEER TYPE SHOULDER PROSTHESIS SYSTEM
K922865 · Osteo Technology, Inc. · Dec 1992
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · Biomet, Inc. · Mar 1992
GLOBAL TOTAL SHOULDER
K914695 · Depuy, Inc. · Jan 1992
GLOBAL TOTAL SHOULDER
K905786 · Depuy, Inc. · Mar 1991
NEER-III GLENOID RESURFACING PROSTHESIS
K873104 · Kirschner Medical Corp. · Oct 1987
NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.
K873620 · Kirschner Medical Corp. · Oct 1987