Cleared Traditional

K993583 - ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993583 · Stryker Corp. · Ear, Nose, Throat device
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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
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.