Cleared Special

K990923 - TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO

K990923 is an FDA 510(k) clearance for TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, manufactured by Heinz Kurz. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Special 510(k) pathway after a 12-day FDA review.

K990923 · Heinz Kurz · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
12d
Days
Class 2
Risk

K990923 is an FDA 510(k) clearance for the TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Heinz Kurz (Dusslingen, DE). The FDA issued a Cleared decision on March 31, 1999 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Heinz Kurz devices

FDA 510(k) Submission Details - K990923

510(k) Number K990923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date March 31, 1999
Days to Decision 12 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

ETB Device Classification - Class 2, Special Controls

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
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 - ETB Prosthesis, Partial Ossicular Replacement

All 37
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K990923.
WEHRS INCUS-STAPES
K000858 · Gyrus Ent LLC · Apr 2000
CAP PORP, CAP TORP
K000256 · Gyrus Ent LLC · Feb 2000
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · Micromedics, Inc. · Nov 1999
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · Exmoor Plastics , Ltd. · May 1998
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997