Trebay Partial Rectrangular Heads, Moretz Cam, Incus/Stapedial Joint & Straight Incus Strut

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

510(k) Number

K954517 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• AT2 & Doyle Style (C-Flex) Vent Tubes

  Class II

  FDA 510(k) K954795 Active Cleared 15 Nov 1995

• Redi Drill Drill System

  Class I

  FDA 510(k) K952609 Active Cleared 31 Jul 1995

• Trebay Irrgated Cutter Blade

  Class I

  FDA 510(k) K951526 Active Cleared 12 May 1995

• Trebay Total Rectangular Head

  Class II

  FDA 510(k) K954518 Active Cleared 27 Oct 1995

• Micro-Planer Handpiece

  Class II

  FDA 510(k) K954715 Active Cleared 27 Oct 1995

• Sof - Abrasion Bur

  Class I

  FDA 510(k) K955294 Active Cleared 22 Dec 1995

See all devices from Trebay Medical Corp. →

• What is the Trebay Partial Rectangular Heads Prosthesis used for?

  This device is designed to restore or augment damaged ossicles in the middle ear, specifically for partial ossicular chain reconstruction. It includes a partial rectangular head, Moretz cam mechanism, and components for the incus/stapedial joint and straight incus strut, enabling improved articulation and sound transmission during otologic procedures.

• How is the Trebay Partial Rectangular Heads Prosthesis supplied?

  The prosthesis is supplied sterile and pre-packaged as a complete set, ready for use in operating rooms. It is intended for single-use only, ensuring compliance with surgical standards and minimizing infection risk.

• Is this device reusable or intended for single-use?

  The Trebay Partial Rectangular Heads Prosthesis is explicitly intended for single-use. This design choice aligns with best practices for sterile surgical implants, reducing cross-contamination risks and ensuring patient safety.

• What sizes or models are available for this ossicular prosthesis?

  The device is available in multiple configurations, as indicated by the listed FEI numbers (e.g., 3003051996, 3003495548, etc.), which correspond to different model variants. These variations accommodate different anatomical requirements for incus/stapedial joint and straight incus strut applications. Contact Trebay Medical Corp. for specific model details.

• How should the Trebay Partial Rectangular Heads Prosthesis be stored?

  The prosthesis should be stored in its original sterile packaging until use. Ensure the packaging remains intact and protected from contamination. Once opened, it must be used immediately, as it is intended for single-use only. Store in a clean, dry environment away from direct sunlight or extreme temperatures.