Profemur TL Hip Stem
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K060358
Overview
The Profemur TL Hip Stem is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for orthopedic use. This device is intended for femoral replacement in total hip arthroplasty, providing a metal stem that integrates with bone without cement fixation to restore joint function and mobility.
The device is supplied as a reusable orthopedic implant, intended for use in sterile surgical environments. It is classified under Device Class III and has received FDA 510K clearance under the Special 510(k) program. Multiple registration numbers and FEI numbers are associated with its regulatory submission, reflecting its compliance with U.S. medical device regulations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060358 | Date10 May 2006 | 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- Withdrawn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 is the Profemur TL Hip Stem primarily used for in surgical procedures?
The Profemur TL Hip Stem is designed specifically for femoral replacement during total hip arthroplasty. It serves as a metal stem that integrates with bone without cement fixation, helping to restore joint function and mobility in patients requiring hip joint replacement.
Is the Profemur TL Hip Stem intended for single-use or reusable applications?
The device is explicitly described as a reusable orthopedic implant, meaning it is intended for use in multiple surgical procedures after proper sterilization and handling in sterile surgical environments.
How is the Profemur TL Hip Stem regulated in the U.S., and what does that mean for its use?
The Profemur TL Hip Stem is classified under Device Class III and has received FDA 510K clearance through the Special 510(k) program. This classification indicates it is a higher-risk device, and its clearance means it is deemed substantially equivalent to a predicate device already on the market, ensuring it meets regulatory standards for safety and effectiveness.
What type of surgical environment is required for the use of this device?
The device is intended for use in sterile surgical environments, as it is a reusable implant that must be properly sterilized before each procedure to prevent infection and ensure patient safety.
Does the Profemur TL Hip Stem have any specific constraints or design features that differentiate it from other hip stems?
Yes, the Profemur TL Hip Stem is described as a semi-constrained metal prosthesis, meaning it provides a balance of stability and flexibility to accommodate the natural movement of the hip joint while being uncemented—meaning it relies on bone integration rather than adhesive fixation for stability.