Depuy 3 Bone Cement

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Depuy 1 Bone Cement

Generic Name

BONE CEMENT

PMA Number

P960001 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

APRL

• 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 orthopedic procedures is this bone cement specifically authorized for use in?

  This bone cement is authorized for use in orthopedic musculoskeletal surgical procedures where prosthetic components need to be fixed to living bone. Specifically, it is indicated for conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction (often secondary to trauma or other conditions), and revision arthroplasty. It is not intended for general bone stabilization but rather for scenarios requiring durable fixation of prosthetic implants.

• How is the Depuy Bone Cement supplied, and is it reusable?

  The Depuy Bone Cement is supplied as a sterile, two-part system that requires mixing prior to use. It is explicitly intended for single-use only, meaning each package is designed for one surgical procedure and should not be reused. This ensures sterility and safety for the patient.

• What regulatory pathway does this bone cement follow, and what does that mean for its use?

  This bone cement follows the FDA Premarket Approval (PMA) pathway, which is a rigorous review process for higher-risk medical devices. The approval (PMA Number P960001) confirms that the device meets FDA standards for safety and effectiveness in its intended use—fixing prosthetic components to bone during orthopedic procedures. This does not imply routine clearance but rather a thorough evaluation of clinical data and manufacturing controls.

• Are there different sizes or models of this bone cement, and how would I identify them?

  The provided data lists multiple FEI numbers (e.g., 3002807305, 2649614) associated with this bone cement, which likely correspond to different lot numbers, batch identifiers, or variations in packaging. While the core product remains a polymethylmethacrylate (PMMA) bone cement, these identifiers help track regulatory compliance and inventory. For specific sizing or model distinctions, refer to the manufacturer’s labeling or packaging, as the data does not detail variations in composition or application.

• Is this bone cement compatible with MRI procedures, and what should I consider when storing it?

  The provided data does not specify MRI safety for this bone cement, so its compatibility with MRI environments cannot be confirmed. For storage, the cement is supplied in a sterile, two-part system, so it should be kept in a dry, sealed environment away from extreme temperatures until use. Always follow the manufacturer’s instructions for optimal shelf life and handling, as improper storage could compromise sterility or performance.