Kurz K-Piston Titanium Stapedial Prosthesis Model 1006 103-1006 170

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

Full name

Kurkz K-Piston Titanium Stapedial Prosthesis, Model 1006 103-1006 170

510(k) Number

K002221 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Heinz Kurz GmbH Medizintechnik →

• What is the primary purpose of the K-Piston Titanium Stapedial Prosthesis Model 1006 103-1006 170 in clinical practice?

  This device is designed to restore conductive hearing by replacing damaged or missing parts of the ossicular chain in the middle ear. It is specifically intended for surgical use to improve sound transmission from the tympanic membrane to the inner ear, commonly addressing conditions like otosclerosis or trauma-related ossicular disruption.

• Is the K-Piston Titanium Stapedial Prosthesis reusable or intended for single-use, and how should it be stored?

  The device is supplied sterile and intended for single-use only. To maintain sterility, it must be stored in a dry environment, protected from moisture and physical damage, until the time of surgical use.

• Can this prosthesis be used in patients who require MRI scans, and if so, are there any restrictions?

  Yes, the K-Piston Titanium Stapedial Prosthesis is non-magnetic and MRI-safe, meaning it can be used in patients who require MRI imaging without reported restrictions. However, always verify compatibility with the specific MRI system and protocol being used.

• What regulatory pathways does this device follow, and which advisory committee was involved in its FDA clearance?

  The device was cleared under the FDA 510(k) pathway as substantially equivalent to a predicate device, with review by the Ear, Nose, and Throat (EN) Advisory Committee. It is also classified as a Class II medical device under the Medical Device Directive (MDD) in Europe.

• What material is the prosthesis made of, and does this affect its compatibility with the body?

  The prosthesis is constructed from titanium, a biocompatible material that is well-tolerated by the body. Titanium’s properties make it suitable for long-term implantation in the middle ear without adverse reactions.