Profemur Z Revision Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K122778
Overview
The Profemur Z Revision Hip Stem is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for use in total hip arthroplasty. It serves as a modular, cementless titanium alloy implant intended to replace damaged or diseased hip joints, providing structural support and restoring function.
Implanted in clinical settings by orthopedic surgeons, the device is available in nine sizes (3–11) and features a heavy grit-blasted surface for enhanced osseointegration. Supplied sterile for single-use, it is classified under FDA regulation 888.3330 and holds a FDA 510(k) clearance (K122778) as substantially equivalent to predicate devices. No MRI safety information or reusable specifications are provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122778 | Date11 Oct 2012 | 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- Withdrawn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 clinical scenarios is the Profemur Z Revision Hip Stem intended for, and how does its design support those needs?
The Profemur Z Revision Hip Stem is designed for total hip arthroplasty in patients with damaged or diseased hip joints requiring replacement. Its semi-constrained, modular, and cementless titanium alloy construction provides structural support and promotes osseointegration through a heavy grit-blasted surface, which enhances bone integration. This makes it suitable for revision surgeries where stability and long-term fixation are critical.
How many sizes are available, and what determines the appropriate size selection for a patient?
The Profemur Z Revision Hip Stem comes in nine sizes (3–11) to accommodate varying patient anatomies. Size selection is based on preoperative imaging and measurements of the patient’s femoral canal, ensuring proper fit for optimal stability and function. Orthopedic surgeons typically use templating tools during planning to determine the correct size.
Is the device reusable, or is it intended for single-use only? What does this mean for surgical workflow?
The Profemur Z Revision Hip Stem is sterile and intended for single-use only, as explicitly stated in the device description. This means each implant is packaged for one surgical procedure, reducing the risk of cross-contamination and ensuring sterility. Hospitals must manage inventory accordingly, ordering pre-sterilized units and adhering to single-use protocols to maintain compliance and patient safety.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians or purchasers?
The Profemur Z Revision Hip Stem received FDA 510(k) clearance (K122778) under the Special 510(k) pathway, demonstrating it is substantially equivalent to predicate devices already on the market. This clearance confirms the device meets FDA safety and effectiveness standards for Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) under regulation 888.3330. Clinicians and purchasers can rely on this approval as evidence of rigorous review by the FDA’s Orthopedic (OR) Advisory Committee.