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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 ?
510(k)
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.
FDA-Cleared Indications
- Reattachment of soft tissue to bone in orthopedic surgery.
- Fixation of tendons and ligaments to bone.
- Use in areas of cancellous bone when soft-tissue reattachment is required.
Clinical Applications
- Fixation of a tendon to bone during orthopedic repair.
- Fixation of a ligament to bone during orthopedic reconstruction.
- Soft-tissue reattachment procedures involving cancellous bone.
- Orthopedic soft-tissue fixation in the knee, shoulder, or ankle when indicated by the surgeon.
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.
Practical Considerations
- The surgeon selects the anchor size and configuration based on the anatomy, tissue quality, and repair technique.
- The device should be used only with compatible instruments and according to the manufacturer’s instructions for use.
- MRI safety depends on the device’s material and the specific labeling; confirm the product’s current MRI conditions before scanning.
- Poor bone quality, infection, inadequate tissue quality, or inability to achieve secure fixation may limit use.
- Postoperative activity restrictions and healing time depend on the repaired tissue, fixation strength, and the surgical procedure.
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.