Cleared Traditional

K993583 - ZURICH TITANIUM OSSICULAR REPLACEMENT S...

K993583 is the FDA 510(k) clearance for ZURICH TITANIUM OSSICULAR REPLACEMENT S... by Stryker Corp.. It is a Class 2 Ear, Nose, Throat device (product code ETA) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K993583 · Stryker Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
19d
Days
Class 2
Risk

K993583 is an FDA 510(k) clearance for the ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on November 10, 1999 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - the FDA ear, nose and throat device 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 Stryker Corp. devices

Submission Details

510(k) Number K993583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date November 10, 1999
Days to Decision 19 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETA Replacement, Ossicular Prosthesis, Total

All 16
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K993583.
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
K241269 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
MILLS COLUMELLA PROSTHESIS
K981088 · Exmoor Plastics , Ltd. · Jun 1998
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · Exmoor Plastics , Ltd. · Aug 1997
RICHARDS TORP
K952549 · Smith & Nephew Richards, Inc. · Jul 1995