Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K112616 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Kurz Upper Eyelid Implant- Platinum/Iridium, Models Regular 4007 003-007, Special 4007 002, 4007 008-010

  Class II

  FDA 510(k) K011115 Active Cleared 2 May 2001

• Clip Piston Awengen, Model# 1006 805 - 1006 861

  Class II

  CE/MDD FDA 510(k) K021479 Active Cleared 21 May 2002

• Nitiflex Stapes Prosthesis

  Class II

  CE/MDD FDA 510(k) K130512 Active Cleared 2 Dec 2013

• Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire

  Class II

  CE/MDD FDA 510(k) K071150 Active Cleared 12 Dec 2007

• Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10

  Class II

  FDA 510(k) K000127 Active Cleared 12 Apr 2000

• Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)

  Class II

  FDA 510(k) K973226 Active Cleared 4 Nov 1997

See all devices from Heinz Kurz GmbH Medizintechnik →

• What is the primary purpose of the Nitibond/Nitoplast Stapes Prosthesis in middle ear surgery?

  The Nitibond and Nitoplast Stapes Prostheses are designed to restore conductive hearing by replacing damaged components of the ossicular chain in the middle ear. Their nitinol loop and titanium shaft are engineered to maintain structural integrity while minimizing irritation to surrounding tissues, ensuring stable function post-implantation.

• Are these prostheses reusable or intended for single-use, and how are they supplied?

  These prostheses are explicitly intended for single-use and are supplied sterile. The design—including a flat, wide loop with contact-free zones—reduces tissue trauma, supporting one-time surgical application without risk of reuse-related complications.

• What pre-operative testing tools are included with the Nitibond/Nitoplast Stapes Prosthesis?

  The kit includes a Thermo-Dummy, which allows surgeons to perform pre-operative laser adjustment testing. This ensures precise sizing and customization before implantation, improving procedural accuracy.

• How many sizes/models are available for these prostheses, and how are they categorized?

  Multiple sizes are available, as indicated by the 10+ registration numbers (e.g., 3003051996, 3002807091) under the ETB product code (Partial Ossicular Replacement Prostheses). These correspond to variations in shaft length/loop design to accommodate different anatomical needs.

• What regulatory pathways have these devices undergone, and which medical specialty oversees their evaluation?

  The devices were cleared via FDA 510(k) (K112616) under the Traditional pathway, with a Substantially Equivalent determination by the Ear, Nose, and Throat (ENT) Advisory Committee. In Europe, they comply with the MDD (Medical Device Directive) and are classified as Class II devices.