Ceramic Femoral Head
510(k) K240452
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240452 | Date12 Apr 2024 | 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- Withdrawn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
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Ceramic Femoral Head is a prosthetic component designed for total hip arthroplasty, serving as the femoral head replacement in hip joint implants. Constructed from ceramic material, it is intended to articulate with acetabular components to restore mobility and function in the hip joint, offering durability and reduced wear compared to metal-on-metal alternatives.
This device is supplied as a single-use, sterile implant intended for surgical use in orthopedic procedures. It is classified under product code LZO and has received FDA 510(k) clearance through the Traditional pathway, with a clearance date of April 12, 2024. The device is not labeled for MRI use and must be handled according to standard orthopedic implant protocols, including proper storage and sterilization as per manufacturer guidelines.