RS-CUP Acetabular Prosthesis

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

510(k) Number

K885049 ↗

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

• 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

See all devices from Allo Pro Corp. →

• What types of hip surgeries is the RS-CUP Acetabular Prosthesis designed for, and why is it considered semi-constrained?

  The RS-CUP Acetabular Prosthesis is specifically designed for total hip arthroplasty, where it replaces the damaged acetabulum to provide a stable bearing surface for the femoral head prosthesis. It is classified as semi-constrained because its design allows for some movement between the acetabular component and the femoral head while still offering increased stability compared to fully unconstrained implants. This balance helps reduce dislocation risks while maintaining natural joint motion.

• How many sizes and variants of the RS-CUP Acetabular Prosthesis are available, and how does this affect my selection process?

  The RS-CUP Acetabular Prosthesis comes in multiple sizes and variants, as indicated by the extensive list of registration numbers (e.g., 3020282716, 3007923096, etc.). These variants likely correspond to different diameters, orientations, or structural configurations to accommodate varying patient anatomies and surgical needs. When selecting, ensure the chosen size matches the patient’s acetabular dimensions and the surgeon’s preferred technique for optimal fit and stability.

• Is the RS-CUP Acetabular Prosthesis intended for reuse, or is it meant to be used only once per patient?

  The RS-CUP Acetabular Prosthesis is explicitly supplied sterile for single-use only. This is standard practice for orthopedic implants to ensure patient safety and sterility, as reuse could introduce contamination or compromise structural integrity. Always follow the manufacturer’s instructions for handling and disposal to maintain compliance.

• What storage conditions should I use for the RS-CUP Acetabular Prosthesis to preserve its sterility and functionality?

  While the exact storage instructions aren’t detailed here, sterile medical devices like this typically require protection from moisture, extreme temperatures, and physical damage. Store the prosthesis in its original packaging, away from direct sunlight or heat sources, and adhere to the manufacturer’s expiration date or re-sterilization guidelines if applicable. Always verify the packaging remains intact before use.

• How do I confirm the regulatory compliance of the RS-CUP Acetabular Prosthesis before purchasing or using it?

  The RS-CUP Acetabular Prosthesis holds an FDA 510(k) clearance (K885049) under the classification of a Class III device (regulation 888.3330), demonstrating it meets U.S. safety and effectiveness standards. For full compliance verification, check the registration numbers (e.g., 8043792) against the FDA’s open database or request a copy of the 510(k) summary from Allo Pro Corp. This ensures the device aligns with current regulatory requirements.