Cement Restrictor for Proforma and Perfecta Total

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

510(k) Number

K923909 ↗

FDA Product Code

LZN

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the Cement Restrictor for Proforma and Perfecta Total used for?

  The Cement Restrictor for Proforma and Perfecta Total is designed to restrict or control the flow of polymethylmethacrylate (PMMA) bone cement during orthopedic procedures. It is specifically intended for use with cemented prostheses to prevent overfilling or leakage of cement, ensuring accurate application and minimizing complications like cement extrusion or improper positioning.

• Is the Cement Restrictor for Proforma and Perfecta Total sterile and single-use?

  Yes, the Cement Restrictor for Proforma and Perfecta Total is supplied sterile and packaged for surgical use. It is also intended for single-use only, adhering to standard sterile surgical instrument protocols to maintain safety and efficacy.

• What regulatory classification and clearance does this device have?

  The Cement Restrictor for Proforma and Perfecta Total is classified as a Class II medical device under the FDA’s Special Controls framework (regulation number 878.3300) and has received FDA 510(k) clearance (K923909). It is determined to be substantially equivalent to a predicate device, meeting the requirements for its intended use in orthopedic procedures.

• Can this device be reused?

  No, the Cement Restrictor for Proforma and Perfecta Total is explicitly designed for single-use only. Reuse is not recommended or supported, as it could compromise sterility and device performance, potentially leading to complications during orthopedic procedures.

• What storage and handling guidelines should be followed for this device?

  The Cement Restrictor for Proforma and Perfecta Total should be stored and handled according to standard sterile surgical instrument protocols. This includes maintaining the sterile packaging until immediate preoperative use, protecting it from contamination, and adhering to manufacturer-recommended storage conditions to preserve sterility and functionality.