đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to measure and size patellar bone blocks during orthopedic graft-preparation procedures.
- Intended for use as a surgical instrument in procedures involving preparation of bone blocks for grafting.
Clinical Applications
- Sizing patellar bone blocks for knee ligament reconstruction.
- Measuring bone-block dimensions before graft placement.
- Preparing bone-block grafts for reconstructive orthopedic surgery.
- Use by orthopedic surgical teams in hospital operating rooms and outpatient surgical centers.
Practical Considerations
- The surgeon should select the instrument size and technique appropriate for the patient's anatomy and the planned graft.
- Compatibility with the associated surgical instruments and graft-preparation system should be confirmed before use.
- The device is a surgical instrument, not an implant; it does not remain in the patient after the procedure.
- Cleaning, sterilization, inspection and handling should follow the manufacturer's instructions and facility policy.
- MRI safety depends on the instrument's materials and whether it is present in or near the MRI environment; consult the current manufacturer labeling before MRI use.
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.