Partial Ossicular Replacement Prostheses

• • 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. 3 Apr 2026 Recall initiated FDA recalls Z-2308-2026

510(k) Number

K060518 ↗

FDA product code

ETB

Device class

Class II

Regulation

21 CFR Part 874.3450

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code ETB (Prosthesis, Partial Ossicular Replacement).

• CAUSSE MODIFIED TEFLON PISTON, OTOLOGY by Richard'S Medical Equip., Inc.
• CAUSSE SPONGE BOAT by Treace Medical, Inc.
• APACERAM OSSICULAR PROSTHESIS by Asahi Optical Co. C/O Rosati Associates, P.C.
• SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS by Gyrus Ent LLC
• MCGEE MODIFIED STAINLESS STEEL PISTON by Treace Medical, Inc.
• RICHARDS TOTAL/PARTIAL PROSTHESIS by Gyrus Ent LLC
• INCUDOSTAPEDIAL JOINT by Smith & Nephew Richards, Inc.
• NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS by Heinz Kurz GmbH Medizintechnik
• ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS by Xomed, Inc.
• TEF/WIRE PISTON by River Medical, Inc.

• 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. →