Profemur S Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K041586
Overview
The Profemur S Hip Stem is a modular orthopedic prosthesis designed for total hip arthroplasty, classified as a semi-constrained metal cemented femoral component. It features a cylindrical distal stem with a slotted, splined design and a proximal geometry optimized for bone fixation, including a triplanar flare and plasma-sprayed surface for enhanced osseointegration.
Supplied as a sterile, single-use device, the Profemur S Hip Stem is intended for surgical use in orthopedic settings. It includes a modular neck taper and a polished distal tip, with a lateral shoulder dimple and cross slot for additional stability. The device holds FDA 510(k) clearance under classification III (K041586) and adheres to regulatory standards for orthopedic implants, including specific registration and medical specialty codes for hip prostheses.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041586 | Date9 Jul 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- Withdrawn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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What types of patients is the Profemur S Hip Stem designed for, and how does its design support stability and bone integration?
The Profemur S Hip Stem is designed for patients undergoing total hip arthroplasty requiring a semi-constrained metal cemented femoral component. Its cylindrical distal stem features a slotted, splined design paired with a proximal triplanar flare, which helps distribute loads and improve fixation. The plasma-sprayed surface enhances osseointegration, while the polished distal tip and modular neck taper reduce friction and improve stability during use.
Is the Profemur S Hip Stem intended for reuse, or is it meant to be used only once per patient?
The Profemur S Hip Stem is explicitly supplied as a sterile, single-use device. This ensures patient safety and sterility, as it is not designed or cleared for reuse in multiple procedures.
What additional features does the Profemur S Hip Stem include to enhance its stability during implantation?
The Profemur S Hip Stem incorporates a lateral shoulder dimple and a cross slot in its design, which work together to improve stability during surgical implantation. These features help secure the stem in place and reduce the risk of micromotion, contributing to better long-term fixation.
How was the FDA clearance for the Profemur S Hip Stem determined, and what classification does it fall under?
The Profemur S Hip Stem holds FDA 510(k) clearance under classification III, with a decision code of SESE (Substantially Equivalent Special). This classification indicates that the device was reviewed as substantially equivalent to a legally marketed predicate device, meeting regulatory standards for orthopedic implants.
What storage or handling precautions should be taken with the Profemur S Hip Stem to maintain its sterility?
While the exact storage instructions are not detailed in the provided data, as a sterile, single-use device, the Profemur S Hip Stem should be stored in its original packaging until use. It is critical to follow manufacturer guidelines to preserve sterility, such as avoiding exposure to moisture, heat, or contamination before surgical use.