Keramos Ceramic/Ceramic Total Hip System
by Djo Surgical PMA
Withdrawn
PMA N980003
Overview
The Keramos Ceramic/Ceramic Total Hip System is a semi-constrained hip prosthesis designed for primary total hip arthroplasty. It features a metal/ceramic/ceramic/metal construction, providing a durable bearing surface for joint replacement in patients with inflammatory tissue disorders, degenerative joint disease, or avascular necrosis. The system is intended for cemented or uncemented fixation, depending on clinical needs and patient anatomy.
This device is supplied in multiple configurations, each identified by specific model numbers and registration codes, and is intended for use in orthopedic surgical settings. It is classified as a Class III medical device under FDA regulations and requires approval via a Premarket Approval (PMA) process. Sterility and single-use or reusable status are not specified in the provided data, but the system must comply with applicable manufacturing and quality standards for orthopedic implants. The Keramos system is authorized under PMA number N980003.
Regulatory status
Withdrawn since 26 Nov 2003. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberN980003 | Date26 Nov 2003 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- PMA Number
- FDA Product Code
- MRA
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APWD Approval withdrawn
Other devices from Djo Surgical
Questions
What types of patients is the Keramos Ceramic/Ceramic Total Hip System intended for?
The Keramos system is specifically designed for patients requiring primary total hip arthroplasty due to inflammatory tissue disorders, degenerative joint diseases (such as osteoarthritis, post-traumatic arthritis, or secondary arthritis), or avascular necrosis. It is not intended for revision surgeries or other non-primary indications.
How is the Keramos Ceramic/Ceramic Total Hip System fixed in place during surgery?
The Keramos system is available in configurations for both cemented and uncemented fixation, allowing surgeons to choose the appropriate method based on the patient’s anatomy and clinical needs. This flexibility supports tailored surgical approaches.
What bearing surface does the Keramos system use, and why is it significant?
The Keramos system features a metal/ceramic/ceramic/metal bearing surface, which is designed to provide a durable and low-friction interface for joint replacement. This construction is intended to reduce wear and improve long-term performance, particularly in active patients.
How many model configurations are available for the Keramos system, and how are they identified?
The Keramos system is supplied in multiple configurations, each identified by specific model numbers and registration codes. While the exact number varies, the system includes a range of sizes and designs to accommodate different patient anatomies and surgical preferences.
What regulatory pathway was followed for the Keramos Ceramic/Ceramic Total Hip System, and when was it authorized?
The Keramos system underwent the FDA’s Premarket Approval (PMA) process, which is required for Class III devices. It was authorized under PMA number N980003, with the approval decision made on November 26, 2003, following a review by the Orthopedic (OR) Advisory Committee.