Cleared Traditional

K130512 - NITIFLEX STAPES PROSTHESIS

K130512 is an FDA 510(k) clearance for NITIFLEX STAPES PROSTHESIS, manufactured by Heinz Kurz GmbH Medizintechnik. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K130512 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Dec 2013
Decision
278d
Days
Class 2
Risk

K130512 is an FDA 510(k) clearance for the NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPE.... Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Heinz Kurz GmbH Medizintechnik (Dusslingen, DE). The FDA issued a Cleared decision on December 2, 2013 after a review of 278 days - an extended review 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. 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Heinz Kurz GmbH Medizintechnik devices

FDA 510(k) Submission Details - K130512

510(k) Number K130512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2013
Decision Date December 02, 2013
Days to Decision 278 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
189d slower than avg
Panel avg: 89d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K130512.
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
SMART OFFSET STAPES PISTON
K033554 · Gyrus Ent LLC · Nov 2003
SMITH & NEPHEW PISTONS
K003214 · Gyrus Ent LLC · Oct 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · Gyrus Ent LLC · Oct 2000