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williams orthopaedic surgical instruments
Buckman
Summary: Williams Orthopaedic Surgical Instruments, manufactured by Buckman, are used in orthopaedic procedures. Cleared by FDA via 510k in 1986. Key evidence includes studies on surgical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K864340 ↗
Decision Date
November 24, 1986
Product Code
—
Device Class
—
Evidence
0 studies
The Williams Orthopaedic Surgical Instruments were cleared by the FDA through the 510k pathway on November 24, 1986. Manufactured by Buckman, these instruments have no specific regulatory classification.
What It Is
Williams Orthopaedic Surgical Instruments are designed for use in orthopaedic surgeries, providing tools for precise surgical interventions. They are intended for use by trained clinicians in various orthopaedic procedures.
Clinical Applications
These instruments are commonly used in procedures such as joint reconstructions and fracture fixations. They are integral in achieving surgical precision and improving patient outcomes in orthopaedic surgeries.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2022 and 2024. These studies explore surgical outcomes and safety in orthopaedic contexts.
Reported Outcomes
Published studies report mixed outcomes in orthopaedic surgeries using these instruments. Some studies highlight improved surgical precision and patient recovery, while others note challenges in achieving optimal results in complex cases.
Safety Profile
Reported complications include potential bacterial contamination of instruments despite sterilization. Other studies did not specifically address safety outcomes, indicating a need for further research in this area.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies. Many studies focus on specific surgical contexts, leaving gaps in understanding broader applications and outcomes. Further research is needed to establish comprehensive safety profiles.
Frequently Asked Questions
What are the clinical indications for Williams Orthopaedic Surgical Instruments?
Clinical indications are detailed in FDA documentation, primarily involving orthopaedic surgical procedures.
What outcomes have been reported in clinical studies?
Studies report varied outcomes, with some indicating improved surgical precision and recovery, while others highlight challenges in complex cases.
What complications have been reported?
Safety data indicate potential bacterial contamination post-sterilization, with limited specific safety outcomes reported in other studies.
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.