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Whiteside Acrylic Cement Spacer Sleeve

by Dow Corning Corp. Healthcare Industries Materials

510(k) K844637

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844637 Date19 Jun 1985ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LTC
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Whiteside Acrylic Cement Spacer Sleeve is a Spacer Sleeve designed to facilitate the application of acrylic cement in orthopaedic procedures. It serves as a protective barrier between bone surfaces and the cement, ensuring precise placement and reducing the risk of cement extrusion or overfilling during joint arthroplasty or similar interventions.

This device is supplied as a single-use, sterile component intended for use in surgical settings. It is classified as a Class III medical device under FDA regulations and is authorised via FDA 510(k) clearance (K844637). The sleeve is compatible with standard orthopaedic acrylic cement systems and must be handled under aseptic conditions prior to application. No specific MRI safety classification is noted in the regulatory data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Whiteside Acrylic Cement Spacer Sleeve used for in orthopaedic surgery?

    The Whiteside Acrylic Cement Spacer Sleeve is designed to act as a protective barrier during orthopaedic procedures like joint arthroplasty. It helps ensure acrylic cement is applied precisely between bone surfaces, reducing the risk of cement extrusion or overfilling by containing the cement within a controlled space.

  • Is the Whiteside Acrylic Cement Spacer Sleeve intended for single-use or can it be reused?

    The device is explicitly labeled as a single-use component, meaning it is meant for one-time surgical application only. Reuse is not recommended due to sterility and performance concerns, particularly in aseptic environments.

  • How should the Whiteside Acrylic Cement Spacer Sleeve be stored before use?

    The sleeve must be stored under aseptic conditions to maintain sterility, as it is supplied sterile. Proper storage involves keeping it in its original packaging until immediately before use, ensuring no contamination occurs.

  • What compatibility considerations should clinicians keep in mind when using this device?

    The sleeve is designed to work with standard orthopaedic acrylic cement systems, but compatibility should be verified with the specific cement brand being used. It is not compatible with non-acrylic materials, and proper handling under sterile conditions is critical to avoid compromising its function.