📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use in total hip arthroplasty for patients with a damaged or diseased hip joint.
- Use of acetabular shells with spikes and a mesh ingrowth surface to support fixation in the acetabulum.
- Use in skeletally mature patients when hip joint reconstruction is indicated because of degenerative disease, fracture, or other substantial joint damage, as specified by the applicable device labeling.
Clinical Applications
- Primary total hip replacement for a damaged or diseased hip joint.
- Revision total hip arthroplasty when replacement of an existing hip implant is required, if included in the applicable system labeling.
- Acetabular reconstruction using a shell that can obtain initial fixation with spikes and support bone ingrowth through its mesh surface.
- Use with compatible femoral and bearing components as part of a total hip replacement system.
Practical Considerations
- The system is available in multiple sizes; the surgeon selects components based on the patient's anatomy and the condition of the acetabulum and femur.
- The acetabular shell requires correct preparation of the acetabulum and stable initial fixation to support subsequent bone ingrowth.
- Only components identified as compatible by the manufacturer should be used together; mixing components from different systems can affect fit, wear, and safety.
- MRI safety depends on the complete implanted construct and the conditions specified for the individual components. The implant should be evaluated against current manufacturer MRI labeling before scanning.
- Contraindications and precautions include active or suspected infection, inadequate bone stock or fixation, severe medical conditions that make arthroplasty unsafe, and conditions that may prevent appropriate postoperative rehabilitation.
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.