Profemur Tapered Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K041114
Overview
The Profemur Tapered Hip Stem is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) designed for orthopedic use. It features a tapered wedge geometry with a triple taper philosophy, providing secure fixation through three-point contact with cortical bone for enhanced stability in hip replacement procedures.
This device is intended for surgical use in orthopedic settings and is supplied as a reusable component, cemented into place. It is classified as a Class III medical device under FDA regulations and holds a 510(k) clearance (K041114) for substantial equivalence. The stem is manufactured by Wright Medical Technology Inc. and adheres to regulatory standards outlined in 21 CFR 888.3320.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041114 | Date28 May 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- Withdrawn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
Is the Profemur Tapered Hip Stem designed for primary or revision hip replacement procedures, and how does its fixation method differ from other stems?
The Profemur Tapered Hip Stem is designed for primary hip replacement procedures, specifically as a cemented prosthesis. Its fixation relies on a triple taper geometry, creating three-point contact with cortical bone for enhanced stability. This design contrasts with other stems by emphasizing secure, long-term fixation through mechanical engagement with bone rather than modularity or press-fit techniques.
How is the Profemur Tapered Hip Stem supplied, and what considerations should be made for its reuse in the operating room?
The Profemur Tapered Hip Stem is supplied as a reusable component, intended to be cemented into place during surgery. Since it is not single-use, proper cleaning, sterilization, and maintenance protocols must be followed per manufacturer guidelines to ensure safety and functionality across multiple procedures. Reuse requires adherence to orthopedic best practices for metal implants, including inspection for wear or damage before each use.
What sizes or models of the Profemur Tapered Hip Stem are available, and how does the taper design influence its clinical application?
The Profemur Tapered Hip Stem is available in multiple sizes, as indicated by the extensive list of FEI numbers (e.g., 3020282716, 3007923096) and registration numbers in the data, which correspond to distinct implant dimensions. The triple taper design allows for a snug fit within the femoral canal, accommodating variations in bone morphology while providing stability through cortical engagement—ideal for patients requiring secure fixation in primary hip arthroplasty.
How should the Profemur Tapered Hip Stem be stored to maintain its integrity before use, and are there any special handling requirements?
The Profemur Tapered Hip Stem should be stored in a clean, dry environment protected from moisture, corrosion, or physical damage. Since it is a metal cemented prosthesis, it must be kept in its original packaging until ready for surgical use. Proper storage ensures sterility (if pre-sterilized) and prevents contamination or degradation of the taper geometry, which is critical for its intended fixation mechanism.