Samuelson Acetabular Cup

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

510(k) Number

K872985 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Clx Acetabular Cup (Wagner) for Cementless Fixat.

  Class III

  FDA 510(k) K870924 Active Cleared 14 Sep 1987

• Femoral Heads/Modular & Fixed W/ Titan Nitride Sur

  Class II

  FDA 510(k) K892059 Active Cleared 19 Jul 1989

• Day Staple

  Class II

  FDA 510(k) K853267 Active Cleared 6 Sep 1985

• New Jersey Femoral Hip Prosthesis for Cement Appli

  Class II

  FDA 510(k) K884789 Active Cleared 8 Feb 1989

• C.S.M. Hip

  Not classified

  FDA 510(k) K862752 Active Cleared 7 Aug 1986

• M.W.P. Wrist Prosthesis

  Class II

  FDA 510(k) K872502 Active Cleared 23 Jul 1987

See all devices from Protek, Inc. →

• What types of hip procedures is the Samuelson Acetabular Cup designed for, and how does it function in those procedures?

  The Samuelson Acetabular Cup is specifically designed for total hip arthroplasty, serving as a replacement for the natural acetabulum. It acts as a stable, semi-constrained metal platform to support femoral components, ensuring proper alignment and even load distribution within the pelvis. This design helps restore hip function and mobility by mimicking the natural anatomy while accommodating the forces of movement.

• Is the Samuelson Acetabular Cup intended for single-use or can it be reused in multiple surgeries?

  The Samuelson Acetabular Cup is explicitly described as a reusable medical implant. Since it is intended for permanent implantation in patients, it is not designed for single-use but rather for long-term use within the body after surgical placement.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical practice?

  The Samuelson Acetabular Cup received FDA clearance through a 510(k) traditional review process, with a determination of substantial equivalence to a predicate device. This means the manufacturer demonstrated that it is as safe and effective as a previously approved, legally marketed device of the same type. Clinically, this clearance indicates the device meets FDA standards for safety and performance, though individual surgeons and hospitals must follow their own protocols for selection and use.

• Are there multiple sizes or models of the Samuelson Acetabular Cup, and if so, how are they differentiated?

  Yes, the Samuelson Acetabular Cup comes in multiple variants, as indicated by the extensive list of registration numbers (e.g., 3020282716, 3007923096) and FEI numbers provided in the data. These identifiers likely correspond to different sizes, diameters, or specific design features tailored to accommodate varying patient anatomies and surgical needs. The exact sizing or model distinctions (e.g., cup diameter, acetabular coverage) are not detailed here, but the diversity of registration numbers suggests customization for different clinical scenarios.