Conserve Plus Revision Shell and Conserve Plus Thick Shell
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K041425
Overview
The Conserve Plus Revision Shell and Conserve Plus Thick Shell are semi-constrained, metal uncemented acetabular components designed for use in total hip arthroplasty. These devices are intended to provide structural support and stability within the acetabulum, facilitating hip joint reconstruction for patients with degenerative joint conditions or structural defects.
These components are supplied as reusable medical devices and are intended for surgical use in orthopedic settings. They are classified as Class III devices under FDA regulations and have received 510(k) clearance (K041425) for use in hip arthroplasty procedures. The devices are not sterile upon receipt and must be sterilized prior to use, adhering to standard medical device sterilization protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041425 | Date25 Jun 2004 | 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- Withdrawn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
Are the Conserve Plus Revision Shell and Thick Shell devices intended for single-use or can they be reused in multiple procedures?
The Conserve Plus Revision Shell and Conserve Plus Thick Shell are explicitly labeled as reusable medical devices for surgical use in total hip arthroplasty. They are not designed for single-use and must be sterilized prior to each procedure according to standard medical device sterilization protocols.
How are the Conserve Plus Revision Shell and Thick Shell devices sterilized before use?
The devices are not sterile upon receipt and must be sterilized prior to use. The manufacturer does not specify a particular sterilization method in the provided data, so it is recommended to follow standard medical device sterilization protocols (e.g., ethylene oxide, autoclave, or gamma irradiation) as determined by your facility’s infection control policies.
What types of hip joint conditions are these devices intended to address?
The Conserve Plus Revision Shell and Thick Shell are semi-constrained, metal uncemented acetabular components designed to provide structural support and stability in the acetabulum during total hip arthroplasty. They are intended for patients with degenerative joint conditions or structural defects requiring hip joint reconstruction, though the exact clinical indications are not detailed beyond this context.
What regulatory pathway was followed for FDA clearance of these devices?
The Conserve Plus Revision Shell and Thick Shell received FDA 510(k) clearance (K041425) under a Special 510(k) review, classified as Substantially Equivalent to a predicate device. The submission was filed under the Orthopedic (OR) Advisory Committee and falls under Class III regulatory classification, as required for high-risk medical devices.
Are there multiple sizes or models available for these devices?
The provided data lists multiple FEI numbers (e.g., 3020282716, 3007923096, etc.), which typically correspond to different sizes, models, or variants of the device. While the exact dimensions or specific model distinctions are not detailed, this suggests the Conserve Plus Revision Shell and Thick Shell come in various sizes to accommodate different patient anatomies or surgical needs.