Prosthetic Cement Remover (LZV)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Prosthetic Cement Remover

510(k) Number

K904180 ↗

FDA Product Code

LZV

Device Class

Class II

Regulation

21 CFR Part 888.4580

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Distention Balloon

  Class II

  FDA 510(k) K953377 Active Cleared 23 Oct 1995

• Laparoscopic Balloon Retractor

  Class II

  FDA 510(k) K914203 Active Cleared 9 Oct 1991

• PSB Preperitoneal Structure Balloon

  Class II

  FDA 510(k) K942636 Active Cleared 1 Jul 1994

• Sensing Tip Surgical Trocar

  Class II

  FDA 510(k) K930848 Active Cleared 1 Mar 1994

• Port-Of-Orgin(Tm) Single-Use Trocar and Sleeve

  Class II

  FDA 510(k) K904848 Active Cleared 8 Apr 1991

• Arthroscopic Tubing Sheath

  Class II

  FDA 510(k) K896584 Active Cleared 27 Dec 1989

See all devices from Origin Medsystems, Inc. →

• What is the Prosthetic Cement Remover (LZV) used for in surgery?

  The Prosthetic Cement Remover (LZV) is specifically designed for use during revision joint replacement surgery to remove prosthetic cement from bone surfaces. Its purpose is to ensure the surgical site is cleaned and prepared precisely before further orthopedic procedures.

• Is this device reusable or single-use, and how is it supplied?

  The Prosthetic Cement Remover (LZV) is supplied as a reusable surgical instrument system, meaning it is intended for multiple uses after proper cleaning and maintenance. It is not a single-use device, and no explicit sterility requirements are mentioned in the provided data.

• What types of joint surgeries is this device intended for?

  While the device is classified under FDA product code LZV for orthopedic applications, its specific indication is for revision joint replacement surgeries—particularly where prosthetic cement removal is required. It is not intended for primary joint replacements or non-orthopedic procedures.

• How was the FDA clearance for this device determined, and what review pathway was used?

  The Prosthetic Cement Remover received FDA clearance through the Traditional 510(k) review pathway under the Orthopedic (OR) Advisory Committee. The decision was based on a finding of substantial equivalence (SESE) to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously cleared product.

• Are there any special storage or handling instructions mentioned for this device?

  The provided data does not specify any sterility requirements, storage conditions, or special handling instructions for the Prosthetic Cement Remover (LZV). Since it is reusable, proper cleaning and maintenance protocols would typically apply, but these details would need to be referenced in the manufacturer’s instructions for use.