Nitiflex Stapes Prosthesis

No FDA recalls on record, checked 6 Oct 2026.

Full name

Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis

510(k) Number

K130512 ↗

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 are the key differences between the Detroit Piston, Skarzynski Piston, and Roberson Stapes Prosthesis variants of the Nitiflex Stapes Prosthesis?

  The Nitiflex Stapes Prosthesis comes in three variants—Detroit Piston, Skarzynski Piston, and Roberson Stapes Prosthesis—each designed for specific surgical applications in otologic procedures. While the exact anatomical or functional distinctions between these models aren’t detailed here, they are tailored to address particular ossicular chain reconstruction needs. The choice of variant depends on the patient’s anatomy and the surgeon’s preference for restoring conductive hearing in the middle ear.

• How should the Nitiflex Stapes Prosthesis be stored to maintain sterility?

  The Nitiflex Stapes Prosthesis is supplied sterile and must be handled according to standard sterile surgical instrument protocols. Since it is intended for single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures sterility and functionality until use in an otolaryngology setting.

• Are multiple sizes available for the Nitiflex Stapes Prosthesis, and why is this important?

  Yes, the Nitiflex Stapes Prosthesis is available in multiple sizes to accommodate individual anatomical variations in the middle ear. This flexibility is critical because the ossicular chain’s structure varies from patient to patient, and selecting the correct size ensures proper fit, stability, and effective conductive hearing restoration during surgery.

• Is the Nitiflex Stapes Prosthesis reusable, or is it intended for single-use?

  The Nitiflex Stapes Prosthesis is explicitly intended for single-use only. This design choice aligns with sterile surgical practices, reducing the risk of cross-contamination and ensuring patient safety. After use, it should be disposed of according to medical waste protocols.

• What regulatory pathways does the Nitiflex Stapes Prosthesis follow, and how does this affect its use?

  The Nitiflex Stapes Prosthesis is authorized under both FDA 510(k) clearance and the Medical Devices Directive (MDD), classifying it as a Class II medical device. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in reconstructing the ossicular chain within otolaryngology. Clinicians and buyers can rely on these authorizations to confirm its compliance with applicable standards.