Perfecta Revision Hip System
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K955553
Overview
The Perfecta Revision Hip System is a semi-constrained, uncemented prosthesis designed for total hip arthroplasty. It consists of metal and polymer components intended to restore hip function and alleviate pain in patients with degenerative joint conditions or failed prior hip implants. This device is classified as a hip prosthesis under product code LWJ and is intended for revision surgeries where stability and longevity are critical. Its semi-constrained design provides enhanced rotational stability while maintaining the natural motion of the hip joint.
The Perfecta Revision Hip System is supplied as a sterile, single-use device for surgical use in orthopedic settings. It is intended for use by trained surgeons in orthopedic revision procedures and requires proper handling and storage as per manufacturer guidelines. The system’s uncemented design relies on osseointegration for fixation, necessitating appropriate patient bone quality and surgical technique. FDA clearance (510(k) K955553) confirms its compliance with regulatory standards for Class II orthopedic devices under special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955553 | Date24 Oct 1996 | 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- Withdrawn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
- LWJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What is the Perfecta Revision Hip System designed for?
The Perfecta Revision Hip System is specifically engineered for total hip arthroplasty revision surgeries. Its semi-constrained, uncemented design ensures enhanced rotational stability while allowing the hip joint to move naturally, making it ideal for patients with degenerative joint conditions or those requiring replacement of failed prior hip implants. The uncemented approach relies on osseointegration—where bone grows into the prosthesis—for long-term fixation, which is critical in revision cases where bone quality may vary.
How is the Perfecta Revision Hip System supplied and prepared for use?
The Perfecta Revision Hip System is supplied as a sterile, single-use device, ensuring safety and compliance with surgical standards. It is intended exclusively for use in orthopedic revision procedures by trained surgeons. Proper handling and storage are essential, as outlined in the manufacturer’s guidelines, to maintain sterility and functionality until surgical use. The system’s components are not reusable, aligning with best practices for infection control and patient safety.
What distinguishes the semi-constrained design of this hip prosthesis?
The semi-constrained design of the Perfecta Revision Hip System balances stability and mobility. Unlike fully constrained implants, which restrict movement more rigidly, this system provides enhanced rotational stability while still allowing the hip joint to move naturally. This design is particularly beneficial in revision surgeries, where maintaining joint function is critical while ensuring the prosthesis remains securely positioned in the bone.
Are there different sizes or models available for the Perfecta Revision Hip System?
While the provided data does not specify exact sizes or model variations, the Perfecta Revision Hip System is designed to accommodate a range of anatomical needs in revision hip arthroplasty. Manufacturers typically offer multiple femoral and acetabular component sizes to match patient-specific bone morphology and surgical requirements. For precise sizing, surgeons rely on preoperative planning and intraoperative assessment to select the optimal components for stability and fit.
How should the Perfecta Revision Hip System be stored before use?
The Perfecta Revision Hip System must be stored in accordance with the manufacturer’s instructions to preserve sterility and integrity. This typically involves keeping the device in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the components remain uncontaminated and ready for surgical use, adhering to orthopedic best practices for implant handling.