Conserve Bio Foam Shell
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K110029
Overview
The Conserve Bio Foam Shell is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for cementless total hip arthroplasty. It serves as a monoblock acetabular cup, providing structural support and integration with surrounding bone to replace the natural acetabulum in degenerative joint disease or functional deformity cases.
Implanted by orthopedic surgeons in a clinical or hospital setting, the device is intended for single-use and is classified as a Class III medical device under FDA regulations (888.3330). Supplied sterile, it requires no additional sterilization and is regulated under the FDA 510(k) clearance (K110029) with a product code of KWA. Multiple acetabular cup sizes are available to accommodate varying patient anatomies.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110029 | Date19 Apr 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of patients is the Conserve Bio Foam Shell designed to support, and how does it differ from cemented acetabular components?
The Conserve Bio Foam Shell is specifically designed for patients undergoing cementless total hip arthroplasty due to degenerative joint disease or functional deformity of the acetabulum. Unlike cemented components, it integrates directly with the surrounding bone without the use of bone cement, relying on its metal construction and foam shell design to provide structural support and promote osseointegration. This makes it suitable for patients where cementless fixation is preferred or clinically appropriate.
How is the Conserve Bio Foam Shell supplied, and does it require any special handling before use?
The Conserve Bio Foam Shell is supplied sterile and is intended for single-use only, meaning no additional sterilization is required before implantation. Since it is sterile out of the package, it should be handled using aseptic techniques to maintain sterility until use in a clinical or hospital setting. Proper storage conditions should be followed to preserve its integrity.
What size options are available for the Conserve Bio Foam Shell, and how does this accommodate different patient anatomies?
The Conserve Bio Foam Shell comes in multiple acetabular cup sizes to accommodate varying patient anatomies. The exact range of sizes is not specified here, but the availability of diverse options ensures that surgeons can select a component that best fits the patient’s specific pelvic anatomy, promoting optimal placement and stability during total hip arthroplasty.
Is the Conserve Bio Foam Shell regulated under a specific FDA pathway, and what does that mean for its use in clinical settings?
Yes, the Conserve Bio Foam Shell is regulated under the FDA 510(k) clearance pathway with the clearance number K110029. This means it has been determined to be substantially equivalent to a legally marketed predicate device and is classified as a Class III medical device under FDA regulations (888.3330). Clinically, this ensures it meets stringent safety and effectiveness standards before being used in hospital or surgical settings.
Can the Conserve Bio Foam Shell be reused, or is it strictly for single-use only?
The Conserve Bio Foam Shell is explicitly designed for single-use only. This is a standard practice for implantable devices to minimize the risk of infection and ensure patient safety. Reusing it would violate medical device guidelines and could compromise sterility and integrity, so it must be discarded after one use.