Drumto Stapes Prosthesis

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

510(k) Number

K832540 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• TEKNA MED Myringotomy Dispos-Oto Kit

  Class II

  FDA 510(k) K813616 Active Cleared 22 Jan 1982

• Otological Ventilation Tubes

  Class II

  FDA 510(k) K802587 Active Cleared 12 Nov 1980

• Surgical Retractor & Elastic Stays, Disp

  Class I

  FDA 510(k) K812562 Active Cleared 2 Oct 1981

• Stainless Steel Pistons

  Class II

  FDA 510(k) K823483 Active Cleared 9 Dec 1982

• What is the primary clinical purpose of the Drumto Stapes Prosthesis and how does it function in the ear?

  The Drumto Stapes Prosthesis is designed to restore conductive hearing by replacing or augmenting the ossicular chain in the middle ear, specifically addressing ossicular discontinuity or erosion involving the stapes. It improves sound transmission from the tympanic membrane to the inner ear, effectively bridging gaps where natural ossicles may be damaged or missing.

• Is the Drumto Stapes Prosthesis intended for reuse or is it meant to be used only once per patient?

  The Drumto Stapes Prosthesis is supplied as a single-use, sterile implant. This means it is intended for one-time surgical use per patient and should not be reused, as reuse could compromise sterility and patient safety.

• What storage conditions should be followed for the Drumto Stapes Prosthesis to maintain its integrity?

  While specific storage instructions are not detailed in the provided data, the prosthesis is supplied as a sterile implant. Generally, sterile medical devices like this should be stored in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight to preserve sterility and functionality until use.

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

  The Drumto Stapes Prosthesis is explicitly noted as not compatible for MRI use. This means it should not be implanted in patients who require MRI imaging, as the magnetic fields could potentially affect the prosthesis or cause safety concerns.

• What regulatory pathway does the Drumto Stapes Prosthesis follow for market distribution in the U.S., and who oversees its approval?

  The Drumto Stapes Prosthesis follows the FDA 510(k) clearance pathway, classified as a Class II medical device under regulation 874.3450. It was originally cleared in 1984 under clearance number K832540 and is regulated through the Ear, Nose, and Throat (ENT) advisory committee, ensuring its safety and effectiveness for surgical use by qualified otologists.