Cleared Traditional

K982981 - NEW ZIMMER SHOULDER SYSTEM

K982981 is an FDA 510(k) clearance for NEW ZIMMER SHOULDER SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K982981 · Zimmer, Inc. · Orthopedic device
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Dec 1998
Decision
113d
Days
Class 2
Risk

K982981 is an FDA 510(k) clearance for the NEW ZIMMER SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 113 days - within the typical 510(k) review window.

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: 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K982981

510(k) Number K982981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1998
Decision Date December 17, 1998
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 K982981.
BIPOLAR SHOULDER PROSTHESIS
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GRIT BLASTED HUMERAL STEM
K991603 · Encore Orthopedics, Inc. · Jun 1999
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K984541 · DePuy Orthopaedics, Inc. · Jan 1999
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
K970567 · Intermedics Orthopedics · Feb 1997
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962315 · Intermedics Orthopedics · Sep 1996
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
K960424 · Endotec, Inc. · Aug 1996