Cleared Traditional

K241269 - mXACT Total Prosthesis Offcenter

K241269 is an FDA 510(k) clearance for mXACT Total Prosthesis Offcenter, manufactured by Med-El Elektromedizinische Ger?te GmbH. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K241269 · Med-El Elektromedizinische Ger?te GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
268d
Days
Class 2
Risk

K241269 is an FDA 510(k) clearance for the mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO.... Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Med-El Elektromedizinische Ger?te GmbH (Innsbruck, AT). The FDA issued a Cleared decision on January 17, 2025 after a review of 268 days - an extended review 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: 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 Med-El Elektromedizinische Ger?te GmbH devices

FDA 510(k) Submission Details - K241269

510(k) Number K241269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2024
Decision Date January 17, 2025
Days to Decision 268 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
179d slower than avg
Panel avg: 89d · This submission: 268d
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 20
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K241269.
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
MODULAR PORP AND TORP MODEL TBD
K002378 · Gyrus Ent LLC · Aug 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · Gyrus Ent LLC · Jul 2000
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583 · Stryker Corp. · Nov 1999
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · Micromedics, Inc. · Aug 1999