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acufex patellar bone block sizer
Acufex Microsurgical
Summary: The Acufex Patellar Bone Block Sizer is a surgical instrument used primarily in orthopedic procedures to measure and prepare bone blocks for grafting. It is typically used by orthopedic surgeons in settings such as hospitals and surgical centers.
FDA Clearance Information
Pathway
510K
Number
K944500 ↗
Decision Date
June 12, 1995
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The Acufex Patellar Bone Block Sizer was cleared through the FDA 510(k) pathway on June 12, 1995. It is manufactured by Acufex Microsurgical and classified as a Class 2 medical device.
What It Is
The Acufex Patellar Bone Block Sizer is a specialized surgical tool designed to assist orthopedic surgeons in accurately sizing patellar bone blocks during reconstructive knee surgeries, such as ACL reconstruction. The device helps ensure that bone grafts are appropriately sized to fit the surgical site, which is crucial for optimal healing and function. It is constructed to provide precise measurements, thereby aiding in the preparation of bone blocks for grafting procedures.
Clinical Applications
This device is commonly used in orthopedic surgical procedures, particularly those involving knee reconstruction, such as anterior cruciate ligament (ACL) repair. It is utilized in hospital operating rooms and outpatient surgical centers by orthopedic surgeons. The primary patient population includes individuals undergoing knee ligament reconstruction, often due to sports injuries or degenerative conditions.
Indications for Use
The FDA indications for the Acufex Patellar Bone Block Sizer relate to its use in measuring and preparing bone blocks for grafting in knee surgeries. It is intended for patients requiring reconstructive knee surgery, particularly those involving ligament repair or replacement.
Practical Considerations
When using the Acufex Patellar Bone Block Sizer, surgeons should ensure compatibility with other surgical instruments and graft materials. The device is available in various sizes to accommodate different patient anatomies and surgical needs. Proper technique in measuring and preparing bone blocks is essential for successful outcomes.
Frequently Asked Questions
What is the Acufex Patellar Bone Block Sizer used for?
It is used for measuring and preparing patellar bone blocks during reconstructive knee surgeries, such as ACL reconstruction.
What specialties typically use this device?
Orthopedic surgeons typically use this device in surgical settings for knee reconstruction procedures.
What are the FDA-cleared indications?
The device is indicated for use in measuring and preparing bone blocks for grafting in knee reconstructive surgeries.
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.