Zirconia Ceramic Femoral Head
by Zimmer, Inc.
510(k) K972690
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK972690 | Date15 Oct 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZO
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 1 Oct 2026
The Zirconia Ceramic Femoral Head is a prosthetic component classified as a femoral head replacement for total hip arthroplasty. It is designed to articulate with acetabular components in hip joint reconstruction, providing a durable, low-friction bearing surface. Manufactured from zirconia ceramic, this device is intended for use in patients requiring hip joint replacement due to degenerative or traumatic joint damage. Its composition offers resistance to wear and corrosion, contributing to long-term implant stability.
This device is supplied as a single-use, sterile implant intended for surgical implantation by orthopedic surgeons in operating room settings. It is supplied in sterile packaging and must be handled using aseptic techniques. The femoral head sizes are standardized to match compatible acetabular components, ensuring proper articulation and joint function. Regulatory clearance for this device was granted under the FDA’s 510(k) pathway, with submissions reviewed by the Orthopedic (OR) Advisory Committee. No MRI safety information is specified in the available data.
Other devices from Zimmer, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Zirconia Ceramic Femoral Head used for?
The Zirconia Ceramic Femoral Head is designed as a prosthetic component for total hip arthroplasty, replacing damaged or degenerative femoral heads in hip joint reconstruction. Its zirconia ceramic material provides a durable, low-friction bearing surface that reduces wear and corrosion, helping to ensure long-term implant stability and joint function.
How is the Zirconia Ceramic Femoral Head supplied and prepared for use?
This device is supplied as a single-use, sterile implant in sterile packaging. It must be handled using aseptic techniques in an operating room setting by orthopedic surgeons during surgery. The packaging ensures sterility until immediate preoperative use, preventing contamination.
Is the Zirconia Ceramic Femoral Head reusable or intended for single use?
The device is explicitly intended for single-use only. Its sterile packaging and design specifications confirm it is not meant for reuse, aligning with best practices for implantable medical devices to minimize infection risks and ensure consistent performance.
What femoral head sizes are available for this device?
The femoral head sizes are standardized to match compatible acetabular components, ensuring proper articulation and joint function. While exact sizes are not listed in the provided data, the design follows industry norms for modularity with common acetabular implants, allowing for precise matching during surgery.
How should the Zirconia Ceramic Femoral Head be stored before use?
The device should be stored in its original sterile packaging in a clean, dry environment protected from physical damage or contamination. Avoid exposure to extreme temperatures or direct sunlight, as these can compromise sterility or material integrity. Follow manufacturer guidelines for expiration dates and storage conditions.