Depuy Cemented Hip Prosthesis

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K942370 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

  Class II

  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →

• What types of patients is this hip prosthesis designed to help, and how does it work in their bodies?

  This prosthesis is specifically designed for patients suffering from degenerative joint disease, fractures, or severe arthritis that affect the hip joint. It works by replacing the damaged joint surfaces with a femoral component that is fixed to the bone using bone cement, restoring stability and function. The closed-design stem and standard collar enhance stability during implantation, allowing patients to regain mobility and reduce pain.

• Is this device meant to be reused after a single surgical procedure, or is it intended for one-time use?

  The Depuy Cemented Hip Prosthesis is supplied sterile and intended for single-use only. Due to its sterile packaging and the nature of orthopedic implants, reuse is not recommended or approved, as it could compromise patient safety and sterility during surgery.

• How should I store this device to ensure it remains effective and safe for use?

  Storage must follow the manufacturer’s guidelines to preserve sterility and structural integrity. Since it is sterile upon receipt, it should be kept in its original packaging until use, protected from contamination, moisture, and extreme temperatures. Avoid exposing it to direct sunlight or rough handling, as this could damage the components before surgery.

• What distinguishes this prosthesis from others in terms of its design, and why might that matter during surgery?

  This prosthesis features a closed-design stem and a standard collar, which are designed to improve stability during implantation. The closed stem reduces the risk of loosening over time, while the collar provides additional support at the junction between the prosthesis and bone. These design elements help ensure a more secure fit, which can be particularly important for patients with complex bone structures or those requiring long-term durability.

• How do I know this device meets regulatory standards, and what does the ‘FDA 510K’ clearance mean for its use?

  The device holds an FDA 510K clearance (K942370), meaning it was determined to be substantially equivalent to a legally marketed predicate device under the traditional orthopedic submission pathway. This clearance confirms that it meets FDA safety and effectiveness requirements for use in total hip arthroplasty when implanted by trained professionals in orthopedic surgery settings. The clearance does not imply it is intended for any specific condition beyond what is described in the device’s labeling.