Titanium Piston 460-575

• FDA 510(k) K060518 decided 28 Jun 2006 Active
• FDA GUDID UDI-DI 00844505014519 listed 5 Aug 2025 Listed

• • Ongoing Z-2308-2026 FDA Class II ·initiated 3 Apr 2026

  Due to incorrect functional length on device labeling.

1. 28 Jun 2006 Cleared FDA 510(k) K060518
2. 5 Aug 2025 Listed FDA GUDID 00844505014519
3. 3 Apr 2026 Recall initiated FDA recalls Z-2308-2026

Trade name

Titanium Piston

Generic name

Ossicular prosthesis, partial

Model / reference

460-575

Primary DI / UDI-DI

00844505014519

510(k) Number

K060518 ↗

FDA product code

ETB

GMDN term

Ossicular prosthesis, partial

Device class

Class II

Regulation number

874.3450

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Ossicular prosthesis, partial

Other devices filed under FDA product code ETB (PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT).

• Kurz K-Piston Titanium Stapedial Prosthesis Model 1006 103-1006 170 by Heinz Kurz GmbH Medizintechnik
• MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Misten Medical Corp.
• H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET by River Medical, Inc.
• POLY-WIRE PISTON by Micromed Development Corp.
• AUDIO TECHNOLOGIES S:R.1 by Audio Technologies S.R.L.
• HAPEX MALLEABLE PORP by Smith & Nephew Richards, Inc.
• MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Micromedics, Inc.
• XOMED PLATINUM WIRE TEFLON PISTION by Xomed, Inc.
• KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 by Heinz Kurz
• mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis by MED-EL Elektromedizinische Geräte GmbH

• Titanium/Fluoroplastic Piston 409-600 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-525 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-550 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-575 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

See all devices from Grace Medical, Inc. →