📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in orthopedic surgery when a washer is needed with a bone screw to distribute mechanical load over the bone surface.
- Use to support stabilization and fixation of bone fragments according to the compatible screw system and surgical technique.
- Use in patients requiring orthopedic internal fixation, as specified by the device labeling and applicable surgical indications.
Clinical Applications
- Fracture fixation with compatible orthopedic screws.
- Stabilization of bone fragments during internal fixation procedures.
- Load distribution over the cortical or other bone surface beneath a screw head.
- Orthopedic reconstructive procedures when the washer is included in the cleared fixation system or technique.
Practical Considerations
- Washers are selected by size, shape, material, and compatibility with the orthopedic screw and the target anatomy.
- The surgeon must ensure that the washer is seated securely on suitable bone and does not impinge on nearby soft tissue or joint structures.
- Contraindications, warnings, material composition, sterilization requirements, and screw compatibility should be verified in the current manufacturer labeling.
- MRI safety cannot be determined from the FDA 510(k) record alone; the specific washer material and labeling should be reviewed before MRI.
- The device is intended for use by qualified orthopedic surgical teams with appropriate instruments and sterile technique.
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.