Cleared Traditional

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

K241269 · Med-El Elektromedizinische Ger?te GmbH · Ear, Nose, Throat
Jan 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K241269 is an FDA 510(k) clearance for the mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit, a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA), submitted by Med-El Elektromedizinische Ger?te GmbH (Innsbruck, AT). The FDA issued a Cleared decision on January 17, 2025, 268 days after receiving the submission on April 24, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number K241269 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code ETA — Replacement, Ossicular Prosthesis, Total
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3495

Similar Devices — ETA Replacement, Ossicular Prosthesis, Total

All 37
GRACE DYNAMIC TORP
K091187 · Grace Medical, Inc. · Sep 2009
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
K083780 · Audio Technologies S.R.L. · Mar 2009
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · Heinz Kurz GmbH Medizintechnik · Oct 2004
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · Invotec International, Inc. · Mar 2003
MODULAR PORP AND TORP MODEL TBD
K002378 · Gyrus Ent LLC · Aug 2000