Prosthesis Wire

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

510(k) Number

K870766 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Mcgee 26GA. Suction Tube

  Class I

  FDA 510(k) K823437 Active Cleared 9 Dec 1982

• Armstrong V Tube Suction Inserter

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  FDA 510(k) K822349 Active Cleared 13 Sep 1982

• Vein Graft Ear Scissors

  Class I

  FDA 510(k) K870756 Active Cleared 3 Mar 1987

• Microsurgical Gauge

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  FDA 510(k) K823436 Active Cleared 9 Dec 1982

• Grommet Vent Tube

  Class II

  FDA 510(k) K823908 Active Cleared 28 Jan 1983

• Universal Speculum Holder

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  FDA 510(k) K822370 Active Cleared 9 Sep 1982

See all devices from Treace Medical, Inc. →

• What is the Prosthesis Wire used for?

  The Prosthesis Wire is intended for partial ossicular replacement in ear, nose, and throat procedures, serving as a prosthetic component for reconstructive purposes in the middle ear to restore hearing function.

• How is the Prosthesis Wire supplied and is it sterile?

  The device is supplied as either a single-use or reusable item, but the provided data does not specify sterility status or sterilization method, so users should consult labeling for exact handling and storage requirements.

• What regulatory pathway was used for the Prosthesis Wire?

  The Prosthesis Wire received FDA 510(k) clearance via the traditional pathway on April 15, 1987, under K number K870766, and is classified as a Class II medical device under product code ETB.

• Are there different sizes or models of the Prosthesis Wire available?

  Yes, the device is available in various sizes and models as indicated by the registration numbers in the OpenFDA data, though specific dimensions or model designations are not detailed in the provided information.