Zweymueller-Sl Hip Prosthesis Stem

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

510(k) Number

K871453 ↗

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

• Zweymuller Cup

  Class III

  FDA 510(k) K851213 Active Cleared 28 May 1985

• 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 types of surgical procedures is the Zweymüller-SL Hip Prosthesis Stem designed for?

  The Zweymüller-SL Hip Prosthesis Stem is specifically designed for total hip arthroplasty procedures, where it is surgically implanted in the proximal femur to replace damaged or diseased femoral heads. It provides structural support and helps restore joint function by serving as a semi-constrained metal uncemented acetabular component.

• Is the Zweymüller-SL Hip Prosthesis Stem intended for reuse or is it single-use?

  The Zweymüller-SL Hip Prosthesis Stem is explicitly intended for single-use in controlled surgical environments. This ensures sterility and safety for each patient, as it is supplied sterile and not designed for repeated use.

• How is the Zweymüller-SL Hip Prosthesis Stem supplied, and what does this mean for handling?

  The device is supplied sterile, meaning it undergoes sterilization processes to eliminate harmful microorganisms before packaging. This ensures it is ready for immediate use in surgery without additional sterilization steps, simplifying handling and reducing contamination risks.

• What regulatory pathway was followed for FDA clearance of the Zweymüller-SL Hip Prosthesis Stem?

  The Zweymüller-SL Hip Prosthesis Stem received FDA 510(k) clearance through a traditional review process, demonstrating it is substantially equivalent to predicate devices. This classification as a Class III medical device reflects its critical role in orthopedic surgery, requiring rigorous evaluation to ensure safety and effectiveness.

• How do I confirm the regulatory compliance of the Zweymüller-SL Hip Prosthesis Stem?

  The device’s regulatory compliance is confirmed through multiple registration numbers and FEI identifiers listed in the FDA database, such as registration number 8043792 and FEI numbers like 3020282716. These identifiers ensure traceability and adherence to FDA requirements for Class III orthopedic implants.