Muller Titanium Backed Acetabular Cup Component

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

510(k) Number

K844482 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Freeman Hip

  Class II

  FDA 510(k) K852839 Active Cleared 29 Oct 1985

• Total Hip Femoral Component

  Class II

  FDA 510(k) K840150 Active Cleared 27 Feb 1984

• Mark I Total Knee Sys. Arthroplasty

  Class II

  FDA 510(k) K832302 Active Cleared 16 Aug 1983

• Yasargil Fenestrated Aneurysm Clip &

  Class II

  FDA 510(k) K833652 Active Cleared 27 Jan 1984

• PM Cementless Screw-In Acetabular Cup

  Class III

  FDA 510(k) K850773 Active Cleared 2 May 1985

• Cls Hip Prosthesis

  Class II

  FDA 510(k) K852517 Active Cleared 18 Sep 1985

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• What types of patients is this acetabular cup component designed to help, and how does it function in total hip arthroplasty?

  This Muller Titanium-Backed Acetabular Cup Component is specifically designed for patients suffering from degenerative joint disease or hip fractures, providing a replacement component to restore hip function and reduce pain. It functions as a semi-constrained metal cemented acetabular prosthesis, meaning it is fixed in place using bone cement during surgery to stabilize the hip joint and improve mobility.

• Is this device intended for reuse, or is it meant to be used only once per patient?

  The Muller Titanium-Backed Acetabular Cup Component is explicitly intended for single-use only in orthopedic surgical settings. It is supplied sterile to ensure safety and efficacy for one surgical procedure per patient, adhering to standard orthopedic best practices for implantable devices.

• What materials is this acetabular cup made from, and how is it secured during surgery?

  This device features a titanium backing with a metal acetabular shell. It is secured during surgery using bone cement, which bonds the component to the patient’s pelvis, ensuring stability and longevity of the implant.

• How should this device be stored before use, and what precautions should be taken?

  Since the Muller Titanium-Backed Acetabular Cup Component is supplied sterile, it must be stored in its original packaging until ready for use to maintain sterility. The packaging should be kept dry, protected from contamination, and within the manufacturer’s recommended temperature and humidity ranges to preserve its integrity and functionality.

• What regulatory pathway was followed for this device’s approval, and which advisory committee was involved?

  This device underwent a Traditional 510(k) review process, determined to be *substantially equivalent* to a predicate device. The Orthopedic (OR) Advisory Committee was involved in the review panel, as indicated by the product code (JDL) and regulatory filings, ensuring compliance with FDA standards for orthopedic implants.