Zweymuller Cup

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

510(k) Number

K851213 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Cementless Zweymueller Hip Endoprothes

  Class II

  FDA 510(k) K822979 Active Cleared 14 Jan 1983

• Biolox Ceramic Ball

  Class II

  FDA 510(k) K892644 Active Cleared 19 Oct 1989

• Centering Plug

  Class II

  FDA 510(k) K900392 Active Cleared 1 Mar 1990

• Zweymueller-Sl Hip Prosthesis Stem

  Class III

  FDA 510(k) K871453 Active Cleared 13 Jul 1987

• Gsb Elbow

  Class II

  FDA 510(k) K901581 Active Cleared 22 Oct 1990

• Weber Permalock

  Class II

  FDA 510(k) K896669 Active Cleared 6 Feb 1990

See all devices from Allo Pro Corp. →

• What is the Zweymüller Cup used for in orthopedic surgery?

  The Zweymüller Cup is a semi-constrained, metal uncemented acetabular component designed specifically for total hip arthroplasty. It serves as the acetabular side of a hip replacement system, providing stability and load-bearing support by articulating with femoral stems during hip replacement procedures. It is intended for surgical use in orthopedic settings.

• Is the Zweymüller Cup intended for single-use or reusable applications?

  The Zweymüller Cup is supplied as a reusable implant. It is intended to be sterilized and used multiple times in surgical settings, though it must be professionally installed by a surgeon during hip replacement procedures.

• How was the Zweymüller Cup regulated by the FDA, and what classification does it fall under?

  The Zweymüller Cup is classified as a Class III device under FDA regulations and was cleared through the 510(k) pathway with the clearance number K851213. It falls under regulation number 888.3330, which pertains to prostheses for hip replacements. The device was determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE.

• What type of sterility assurance is provided for the Zweymüller Cup before surgical use?

  The Zweymüller Cup is supplied as a sterile implant, meaning it undergoes sterilization processes to ensure it is safe for surgical use. However, since it is reusable, it must be properly sterilized between uses in accordance with medical facility protocols.

• Are there different sizes or models of the Zweymüller Cup available?

  The provided data does not specify exact sizes or models of the Zweymüller Cup, but it is described as a semi-constrained acetabular component for hip prostheses. For precise sizing options, refer to the manufacturer’s catalog or technical documentation, as these details are not explicitly listed in the regulatory submission.