Conserve Plus Spiked Acetabular Shells and Conserve Total 56MM Femoral Head
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K031963
Overview
The device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for use in total hip arthroplasty. It consists of spiked acetabular shells and a 56mm femoral head component, intended to provide structural support and articulation in hip replacement procedures.
These components are supplied as single-use items for orthopedic applications, intended to be implanted in skeletally mature patients. The device is classified under FDA regulation 888.3330, with a clearance type designated as Special under the 510(k) process (K031963). No additional sterility or MRI safety specifications are noted in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031963 | Date31 Oct 2003 | 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- Withdrawn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 this device intended for in terms of age and skeletal maturity?
This device is designed for skeletally mature patients undergoing total hip arthroplasty. The spiked acetabular shells and 56mm femoral head are intended for use in adults whose bones have fully developed, ensuring proper structural support and articulation during hip replacement surgery.
Is this device reusable or intended for single-use only?
The CONSERVE PLUS spiked acetabular shells and 56mm femoral head are explicitly supplied as single-use items. They are not intended for reuse after implantation, adhering to standard orthopedic practice for prosthetic components to ensure patient safety and sterility.
What is the regulatory pathway and classification for this device in the U.S.?
This device was cleared through the FDA’s 510(k) process under a Special clearance type (K031963) and falls under regulation 888.3330. It is classified as a Class III device (as per OpenFDA data) and is intended for orthopedic use, specifically as a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component).
Are there any specific storage requirements mentioned for this device?
The provided data does not explicitly detail storage requirements such as temperature or handling conditions. However, as a single-use medical device, it should be stored in a clean, dry environment, protected from contamination, and according to the manufacturer’s instructions (which are not specified here). Always follow Wright Medical’s guidelines for optimal shelf life and sterility.