Cleared Traditional

K993583 - ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM

K993583 is an FDA 510(k) clearance for ZURICH TITANIUM OSSICULAR REPLACEMENT S..., manufactured by Stryker Corp.. The device is a Class 2 Ear, Nose, Throat device with 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

FDA 510(k) Submission Details - K993583

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
71d faster than avg
Panel avg: 90d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K993583.
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · Invotec International, Inc. · Mar 2003
MODULAR PORP AND TORP MODEL TBD
K002378 · Gyrus Ent LLC · Aug 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · Gyrus Ent LLC · Jul 2000
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · Micromedics, Inc. · Aug 1999
BOJRAB MICRO-TORP, MODEL 7014-5845
K990601 · Gyrus Ent LLC · Mar 1999
MILLS COLUMELLA PROSTHESIS
K981088 · Exmoor Plastics , Ltd. · Jun 1998