đź“‹ FDA Reference
osseofit interfacing anchor osseofit bone tunnel construct
Riverpoint Medical
Summary: The Osseofit Interfacing Anchor is a medical device used in orthopedic procedures to secure soft tissue to bone. It is primarily used by orthopedic surgeons in various surgical settings.
FDA Clearance Information
Pathway
510K
Number
K242494 ↗
Decision Date
November 26, 2024
Product Code
MBI
Device Class
Class 2
Evidence
0 studies
The Osseofit Interfacing Anchor by Riverpoint Medical was cleared through the FDA 510(k) pathway on November 26, 2024. It is a Class 2 device under product code MBI.
What It Is
The Osseofit Interfacing Anchor is a surgical device designed to facilitate the attachment of soft tissues, such as tendons or ligaments, to bone. It functions by creating a stable interface within a bone tunnel, providing secure fixation. This device is particularly useful in procedures requiring precise and reliable soft tissue anchoring, such as rotator cuff repairs or ACL reconstructions.
Clinical Applications
Commonly used in orthopedic surgeries, the Osseofit Interfacing Anchor is ideal for procedures like shoulder and knee repairs. It is frequently utilized in sports medicine and orthopedic trauma settings, where secure tissue fixation is critical. The device is suitable for a wide range of patient populations, from athletes to older adults requiring reconstructive surgery.
Indications for Use
The FDA-cleared indications suggest that the Osseofit Interfacing Anchor is intended for use in surgeries where soft tissue needs to be attached to bone. This includes conditions such as tendon tears or ligament injuries that require surgical intervention.
Practical Considerations
The Osseofit Interfacing Anchor comes in various sizes to accommodate different surgical needs and anatomical variations. It is compatible with standard surgical instruments and techniques, ensuring ease of integration into existing surgical workflows.
Frequently Asked Questions
What is the Osseofit Interfacing Anchor used for?
It is used to attach soft tissue, like tendons or ligaments, to bone in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine and trauma surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring the attachment of soft tissue to bone, such as tendon or ligament repairs.
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.