Conserve Plus HA Acetabular Shells
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K042530
Overview
The CONSERVE Plus HA Acetabular Shells are a type of Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for use in total hip arthroplasty. These metal acetabular components are intended to provide structural support and articulation for the hip joint, improving mobility and pain relief in patients with degenerative joint conditions such as osteoarthritis or avascular necrosis.
These shells are supplied sterile and intended for single-use in orthopedic surgical procedures. They are classified as Class III devices under FDA regulations and are regulated under the 510(k) clearance process (K042530). Multiple reference codes (e.g., 3020282716, 1047843) identify distinct sizes and variants, ensuring compatibility with various patient anatomies. Storage and handling must comply with sterile surgical instrument protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042530 | Date17 Dec 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- Withdrawn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 HA Acetabular Shells reusable or intended for single-use in surgery?
The CONSERVE Plus HA Acetabular Shells are explicitly designed for single-use only in orthopedic surgical procedures, as stated in the device description. This aligns with standard sterile surgical instrument protocols to ensure patient safety and prevent cross-contamination.
How many distinct sizes or variants of the CONSERVE Plus HA Acetabular Shells are available, and how do I determine compatibility with a patient?
The device includes multiple reference codes (e.g., 3020282716, 1047843, etc.), each corresponding to a specific size or variant. These codes ensure compatibility with various patient anatomies. Consult the manufacturer’s sizing guides or product documentation to match the correct reference code to the patient’s hip dimensions during preoperative planning.
What storage and handling requirements apply to the CONSERVE Plus HA Acetabular Shells?
Since the shells are supplied sterile, they must be stored and handled according to sterile surgical instrument protocols to maintain integrity. This includes proper packaging, protection from contamination, and adherence to facility-specific sterile storage guidelines (e.g., sealed pouches, sterile trays, or sterile storage cabinets). Always follow the manufacturer’s instructions for unpacking and preparation.
What regulatory pathway was used for FDA clearance of the CONSERVE Plus HA Acetabular Shells, and what does this mean for clinicians?
The device was cleared via the FDA 510(k) process (K042530) under a Special Review with a determination of Substantially Equivalent (SESE) to a predicate device. This classification means the device meets FDA standards for safety and effectiveness as a Class III medical device (orthopedic prosthesis) and is regulated under strict quality controls. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though individual surgical decisions should still follow evidence-based guidelines.