Conserve Total Femoral Head
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K051348
Overview
The Conserve Total Femoral Head is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). This device is designed as a femoral head component for total hip arthroplasty, providing a semi-constrained articulation to restore hip function while maintaining stability. It is intended for use in cemented fixation within the femoral canal, offering a durable solution for patients requiring hip replacement surgery.
This device is supplied as a reusable surgical implant, intended for use in orthopedic procedures under sterile conditions. It is classified as a Class III medical device under FDA regulations and has received FDA 510K clearance under the Traditional 510(k) review process. Multiple reference codes (e.g., 3020282716, 1047843) identify distinct variants, all adhering to the same regulatory framework. Storage and handling must comply with orthopedic implant protocols to ensure sterility and integrity prior to surgical use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051348 | Date19 Aug 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1716-2009
- Terminated Z-1715-2009
Incorrect packaging, swapped sizes
Specification
- 510(k) Number
- FDA Product Code
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of hip replacement surgeries is the Conserve Total Femoral Head designed for, and how does its semi-constrained articulation help patients?
The Conserve Total Femoral Head is specifically designed for total hip arthroplasty procedures where a cemented femoral component is required. Its semi-constrained articulation provides enhanced stability compared to traditional ball-and-socket designs, which helps restore hip function while reducing the risk of dislocation. This design is particularly useful for patients who need durable, long-term support in their hip replacement.
Is the Conserve Total Femoral Head intended for single-use or can it be reused in multiple procedures?
The Conserve Total Femoral Head is supplied as a reusable surgical implant, meaning it is intended for use in multiple orthopedic procedures under sterile conditions. However, proper sterilization and handling protocols must be followed to ensure its integrity and safety for repeated use.
What storage and handling requirements must be followed to maintain sterility and integrity before surgical use?
Since the Conserve Total Femoral Head is a reusable implant, it must be stored and handled according to orthopedic implant protocols to preserve sterility and structural integrity. This includes following manufacturer guidelines for cleaning, sterilization, and packaging to ensure it remains safe for surgical use in subsequent procedures.
How do I identify the different variants of the Conserve Total Femoral Head, and are they all regulated under the same framework?
The Conserve Total Femoral Head comes in multiple variants, each identified by unique FEI numbers (e.g., 3020282716, 1047843). All variants are classified as Class III medical devices and have received FDA 510K clearance under the Traditional 510(k) review process, meaning they are all regulated under the same framework as the original device.