Weill Cementless Threaded Acetabular Cup

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

510(k) Number

K844943 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Freeman Hip

  Class II

  FDA 510(k) K852839 Active Cleared 29 Oct 1985

• Total Hip Femoral Component

  Class II

  FDA 510(k) K840150 Active Cleared 27 Feb 1984

• Mark I Total Knee Sys. Arthroplasty

  Class II

  FDA 510(k) K832302 Active Cleared 16 Aug 1983

• Yasargil Fenestrated Aneurysm Clip &

  Class II

  FDA 510(k) K833652 Active Cleared 27 Jan 1984

• PM Cementless Screw-In Acetabular Cup

  Class III

  FDA 510(k) K850773 Active Cleared 2 May 1985

• Cls Hip Prosthesis

  Class II

  FDA 510(k) K852517 Active Cleared 18 Sep 1985

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• What types of surgical procedures is the Weill Cementless Threaded Acetabular Cup designed for?

  The Weill Cementless Threaded Acetabular Cup is specifically designed for use in total hip arthroplasty procedures. Its uncemented, threaded design is intended to provide secure fixation within the pelvis without relying on bone cement, making it suitable for primary or revision hip replacements where stable osseointegration is critical.

• Is this device intended for reuse in surgical settings, or is it single-use only?

  The Weill Cementless Threaded Acetabular Cup is explicitly supplied sterile and intended for single-use only in orthopedic surgical settings. This ensures patient safety and compliance with sterile procedure protocols.

• What sizes or variants of this acetabular cup are available, and how do I identify them?

  The device comes in multiple sizes and variants, each associated with a unique registration number (e.g., 3020282716, 3007923096, etc.). These numbers are listed in the FDA’s OpenFDA database under the product code KWA and regulation number 888.3330. The exact sizing and specifications should be confirmed with the manufacturer or referenced in the packaging.

• How should the Weill Cementless Threaded Acetabular Cup be stored before use?

  Since the device is supplied sterile, it should be stored in its original, sealed packaging to maintain sterility until the time of use. Proper storage conditions (e.g., temperature, humidity, and protection from contamination) are critical to preserving its integrity. Always follow the manufacturer’s storage instructions provided in the packaging.

• Can this device be used in patients who require MRI imaging after surgery?

  The Weill Cementless Threaded Acetabular Cup is not MRI-safe unless explicitly stated in its packaging or specifications. Patients should be informed of this limitation, and MRI compatibility should be confirmed with the manufacturer or device documentation before proceeding with imaging.