Samuelson Screwloc Cup

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

510(k) Number

K882671 ↗

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

• Samuelson Acetabular Cup

  Class III

  FDA 510(k) K872985 Active Cleared 1 Oct 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

See all devices from Protek, Inc. →

• What types of hip replacement surgeries is the Samuelson Screwloc Cup designed for, and how does its semi-constrained design benefit patients?

  The Samuelson Screwloc Cup is specifically designed for uncemented hip replacement procedures where a stable acetabular component is needed to restore hip joint function. Its semi-constrained metal design provides a fixed bearing surface within the pelvis, which helps reduce dislocation risk and improve stability compared to fully unconstrained cups. This is particularly useful in cases requiring enhanced rotational control while still allowing for some flexibility in movement.

• Is the Samuelson Screwloc Cup intended for reuse, or is it meant to be used only once per patient?

  The Samuelson Screwloc Cup is explicitly intended for single-use in orthopedic settings. It is supplied sterile to ensure patient safety and prevent cross-contamination, which is standard practice for implantable devices like this.

• How do I determine the correct size or model for a patient’s procedure, and are there multiple variations available?

  The Samuelson Screwloc Cup comes in multiple sizes and models, each identified by unique reference codes (e.g., 1000116912, 3002807113). These variations account for differences in patient anatomy and surgical requirements. Your orthopedic surgeon or surgical team will select the appropriate size based on preoperative planning, such as imaging and measurements, to ensure proper fit and function during the hip replacement procedure.

• What storage conditions should be followed for the Samuelson Screwloc Cup to maintain its sterility and integrity?

  While the exact storage instructions are not detailed in the provided data, sterile medical devices like the Samuelson Screwloc Cup typically require protection from moisture, extreme temperatures, and physical damage. They should be stored in their original packaging, away from direct sunlight or heat sources, and in a clean, dry environment. Always follow the manufacturer’s (Protek, Inc.) specific storage guidelines included with the device to preserve sterility and functionality.

• How is the regulatory pathway for this device structured, and what does the FDA’s classification as Class 3 imply for its oversight?

  The Samuelson Screwloc Cup was cleared via the FDA’s 510(k) pathway (K882671) under Traditional review, meaning it was deemed substantially equivalent to a legally marketed predicate device. As a Class 3 device, it is subject to stricter regulatory controls due to its role in sustaining or supporting life, preventing impairment, or presenting a potential unreasonable risk of illness or injury. This classification ensures rigorous premarket approval processes, including clinical data and manufacturing quality standards, to ensure safety and effectiveness.