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ogden anchor for all orthopaedic soft tissue applications
American Medical Electronics
Summary: The Ogden Anchor is a soft-tissue anchoring device used in orthopedic surgeries. It is primarily used for reattachment of soft tissues to bone. Key evidence highlights its effectiveness in various orthopedic applications.
FDA Clearance Information
Pathway
510K
Number
K951545 ↗
Decision Date
July 3, 1995
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Ogden Anchor was cleared by the FDA through the 510(k) pathway on July 3, 1995. It is manufactured by American Medical Electronics and classified as a Class 2 device.
What It Is
The Ogden Anchor is designed for the reattachment of soft tissues to bone, commonly used in orthopedic procedures. It functions by providing secure fixation for tendons and ligaments, facilitating healing and stability.
Clinical Applications
The device is frequently used in surgeries involving the knee, shoulder, and ankle, where soft tissue reattachment is necessary. It is particularly useful in cases with large areas of cancellous bone.
Evidence Summary
The literature includes four studies, ranging from 1997 to 2025, encompassing various study types such as RCTs and case series. These studies evaluate the anchor's effectiveness in orthopedic applications.
Reported Outcomes
Published studies report that the Ogden Anchor is effective in the reattachment of soft tissues to bone, with successful outcomes in orthopedic surgeries. It has been shown to provide reliable fixation in clinical scenarios involving fractures and dislocations.
Safety Profile
Reported complications include potential issues with anchor fixation strength and the need for precise placement to avoid soft tissue damage. However, specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to fully understand long-term efficacy and potential complications.
Frequently Asked Questions
What are the clinical indications for Ogden Anchor?
The Ogden Anchor is indicated for the reattachment of soft tissues to bone in orthopedic surgeries, particularly in the knee, shoulder, and ankle.
What outcomes have been reported in clinical studies?
Studies report effective reattachment of soft tissues with reliable fixation in orthopedic procedures.
What complications have been reported?
Reported complications include potential issues with fixation strength and the need for precise placement to avoid soft tissue 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.