Cleared Traditional

NEW ZIMMER SHOULDER SYSTEM (K982981) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 42
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K982981.
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · Biomet, Inc. · Oct 2000
BIPOLAR SHOULDER PROSTHESIS
K991585 · Biomet, Inc. · Aug 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · DePuy Orthopaedics, Inc. · Jan 1999
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · Biomet, Inc. · Aug 1996
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · Biomet, Inc. · Oct 1994
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · Biomet, Inc. · Mar 1992