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ace orthopaedic washers
Buckman
Summary: Ace Orthopaedic Washers are medical devices used in orthopedic surgeries to distribute load and stabilize bone fragments. They are typically used by orthopedic surgeons in various surgical settings.
FDA Clearance Information
Pathway
510K
Number
K895107 ↗
Decision Date
September 11, 1989
Product Code
HTN
Device Class
Class 2
Evidence
0 studies
The Ace Orthopaedic Washers by Buckman were cleared through the FDA 510(k) pathway on September 11, 1989. They are classified as Class 2 devices under product code HTN.
What It Is
Ace Orthopaedic Washers are small, circular devices used in orthopedic procedures to provide even distribution of load across bone surfaces. They are typically used in conjunction with screws to stabilize bone fragments, ensuring proper alignment and healing. These washers are made from biocompatible materials that integrate well with human tissue.
Clinical Applications
Ace Orthopaedic Washers are commonly used in orthopedic surgeries such as fracture fixation, joint reconstruction, and spinal surgeries. They are particularly useful in procedures requiring the stabilization of bone fragments or the distribution of mechanical load. Orthopedic surgeons in hospital and surgical center settings frequently use these devices, especially for patients with complex fractures or those undergoing reconstructive surgeries.
Indications for Use
The FDA indications suggest that Ace Orthopaedic Washers are intended for use in orthopedic surgeries where stabilization of bone fragments is necessary. They are suitable for patients with fractures or those undergoing reconstructive procedures.
Practical Considerations
Ace Orthopaedic Washers come in various sizes to accommodate different surgical needs and anatomical variations. They are compatible with standard orthopedic screws and require careful placement to ensure optimal load distribution. Surgeons should consider the specific anatomical and mechanical requirements of each procedure when selecting the appropriate washer size.
Frequently Asked Questions
What is Ace Orthopaedic Washers used for?
Ace Orthopaedic Washers are used to stabilize bone fragments and distribute mechanical load in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons typically use Ace Orthopaedic Washers in various surgical settings.
What are the FDA-cleared indications?
The device is indicated for use in orthopedic surgeries requiring stabilization of bone fragments, such as fracture fixation and reconstructive procedures.
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.