Cleared Traditional

K943300 - DEPUY POROUS COATED GLOBAL SHOULDER

K943300 is an FDA 510(k) clearance for DEPUY POROUS COATED GLOBAL SHOULDER, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K943300 · Depuy, Inc. · Orthopedic device
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Oct 1994
Decision
115d
Days
Class 2
Risk

K943300 is an FDA 510(k) clearance for the DEPUY POROUS COATED GLOBAL SHOULDER. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 31, 1994 after a review of 115 days - within the typical 510(k) review window.

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: 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K943300

510(k) Number K943300 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 08, 1994
Decision Date October 31, 1994
Days to Decision 115 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 122d · This submission: 115d
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 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K943300.
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K950521 · Osteonics Corp. · Jun 1995
TOTAL SHOULDER PROSTHESIS
K950651 · Encore Orthopedics, Inc. · May 1995
SELECT(R) SHOULDER ALL POLY GLENOID
K935802 · Intermedics Orthopedics · May 1995
3M MODULAR SHOULDER SYSTEM
K920362 · 3M Health Care, Ltd. · Jul 1993
NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
K902855 · Depuy, Inc. · Sep 1990
PAPILLOTOME
K901434 · Telemed Systems, Inc. · Jun 1990