PTFE Piston

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K913285 ↗

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 River Medical, Inc. →

• What is the PTFE Piston used for?

  The PTFE Piston is designed as a Prosthesis, Partial Ossicular Replacement to restore conductive hearing. It replaces or augments damaged ossicles in the middle ear, improving sound transmission from the tympanic membrane to the inner ear. This is particularly useful in cases where ossicular chain disruption impairs hearing.

• How is the PTFE Piston supplied and is it sterile?

  The PTFE Piston is supplied sterile and intended for single-use only. This ensures safety and reduces the risk of infection during surgical implantation, adhering to best practices for medical devices used in delicate procedures like otologic surgery.

• What sizes and configurations are available for the PTFE Piston?

  The PTFE Piston comes in standardized sizes and configurations specifically designed for surgical application in the ear. These variations allow for precise fitting during partial ossicular replacement procedures, ensuring optimal performance and compatibility with the patient’s anatomy.

• Can the PTFE Piston be used in an MRI environment?

  Yes, the PTFE Piston is non-magnetic, making it compatible with MRI environments. However, standard safety protocols for MRI should still be followed during and after implantation to ensure patient safety and device integrity.

• What regulatory approval does the PTFE Piston hold?

  The PTFE Piston has received FDA 510(k) clearance (K913285) and is classified as a Class II medical device under FDA regulations (21 CFR 874.3450). This clearance confirms its substantial equivalence to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.