đź“‹ FDA Reference
howmedica asymmetric stem vitalock cluster spiked shells and acetabular shells with mesh ingrowth surface with peri-a
Howmedica
Summary: The Howmedica Asymmetric Stem Vitalock is a medical device used in orthopedic procedures, specifically for hip replacements. It is primarily used by orthopedic surgeons to improve joint stability and patient mobility.
FDA Clearance Information
Pathway
510K
Number
K982248 ↗
Decision Date
August 31, 1998
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The Howmedica Asymmetric Stem Vitalock was cleared through the FDA 510(k) pathway on August 31, 1998. Manufactured by Howmedica, it is classified as a Class 2 device under product code LPH.
What It Is
The Howmedica Asymmetric Stem Vitalock is an orthopedic implant designed for hip arthroplasty. It features a cluster spiked shell and an acetabular shell with a mesh ingrowth surface, which aids in the biological fixation process. This design enhances the stability of the implant by promoting bone ingrowth, which is crucial for long-term success in hip replacement surgeries.
Clinical Applications
This device is commonly used in total hip replacement surgeries, particularly in patients requiring revision surgeries or those with complex hip anatomy. It is utilized in orthopedic settings, including hospitals and specialized surgical centers. The target patient population includes adults with degenerative hip diseases, such as osteoarthritis, or those who have experienced hip fractures.
Indications for Use
The FDA indications suggest that this device is intended for patients undergoing hip replacement surgery. It is particularly suited for individuals with hip joint degeneration or damage that necessitates surgical intervention to restore function.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is compatible with other standard hip replacement components. Surgeons should be familiar with the specific implantation technique required for optimal outcomes.
Frequently Asked Questions
What is Howmedica Asymmetric Stem Vitalock used for?
It is used in hip replacement surgeries to provide joint stability and facilitate bone ingrowth for long-term implant success.
What specialties typically use this device?
Orthopedic surgeons specializing in hip arthroplasty and joint replacement procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients undergoing hip replacement surgery due to joint degeneration or damage.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.