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hap bio-groove total hip prosth bio-interfaces
Biomet
Summary: The hap bio-groove total hip prosth bio-interfaces is a hip prosthesis used in total hip replacement surgeries. It is primarily used by orthopedic surgeons to restore hip function in patients with severe joint damage.
FDA Clearance Information
Pathway
510K
Number
K912370 ↗
Decision Date
October 11, 1991
Product Code
MEH
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 11, 1991. It is manufactured by Biomet and classified as a Class 2 medical device.
What It Is
The hap bio-groove total hip prosth bio-interfaces is a hip prosthesis designed for use in total hip arthroplasty. It features a hydroxyapatite (HAP) coating that promotes bone growth and integration with the implant. This device is intended to replace the hip joint in patients with severe arthritis or hip damage, providing improved mobility and pain relief.
Clinical Applications
This hip prosthesis is commonly used in orthopedic surgery for patients requiring total hip replacement due to osteoarthritis, rheumatoid arthritis, or traumatic injury. It is typically used in hospital settings by orthopedic surgeons. The device is suitable for adult patients experiencing significant hip pain and mobility issues that have not responded to conservative treatments.
Indications for Use
The device is indicated for patients who need a total hip replacement, particularly those with severe joint damage from arthritis or injury. It is designed to restore hip function and alleviate pain.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies. Surgeons should ensure compatibility with other components of the hip replacement system. Proper surgical technique is crucial for optimal outcomes and longevity of the implant.
Frequently Asked Questions
What is hap bio-groove total hip prosth bio-interfaces used for?
It is used for total hip replacement surgeries to restore hip function and alleviate pain in patients with severe joint damage.
What specialties typically use this device?
Orthopedic surgeons typically use this device in the context of hip replacement surgeries.
What are the FDA-cleared indications?
The device is indicated for patients needing a total hip replacement due to severe arthritis or hip 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.