Cleared Traditional

K193180 - Alliance Augmented Glenoid

K193180 is the FDA 510(k) clearance for Alliance Augmented Glenoid by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K193180 · Zimmer, Inc. · Orthopedic device
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Feb 2020
Decision
98d
Days
Class 2
Risk

K193180 is an FDA 510(k) clearance for the Alliance Augmented Glenoid. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 24, 2020 after a review of 98 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 Zimmer, Inc. devices

Submission Details

510(k) Number K193180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2019
Decision Date February 24, 2020
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K193180.
Global Shoulder and Delta CTA systems
K203230 · Depuy Lnc. · Apr 2021
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K203026 · Encore Medical, L.P. · Dec 2020
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K202289 · Stryker GmbH · Dec 2020
SmartSPACE Shoulder System
K191247 · Techmah Medical, LLC · Nov 2019
Alliance Glenoid
K191814 · Zimmer, Inc. · Oct 2019
Materialise Glenoid Positioning System
K190286 · Materialise NV · Jul 2019