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This document provides a summary of the safety and effectiveness of the Unicompartmental and Bicompartmental Knee System Instruments by Smith & Nephew, detailing their indications for use, device
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How to fill out Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments
01
Gather all necessary documentation related to the Unicompartmental and Bicompartmental Knee Systems.
02
Start by filling out the general information section, including product names, manufacturers, and submission date.
03
Provide a detailed description of the devices, including their design, materials, and intended use.
04
Include information on the clinical studies conducted to evaluate safety and effectiveness.
05
Summarize the results of the clinical studies, highlighting key findings and any adverse events.
06
Discuss the risks associated with the devices and how they are mitigated.
07
Outline the regulatory compliance and any previous approvals by relevant authorities.
08
Review the document for completeness and accuracy before final submission.
Who needs Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments?
01
Orthopedic surgeons who are considering using these knee systems in their practice.
02
Medical device regulatory professionals who need to evaluate compliance and safety.
03
Hospitals and healthcare facilities conducting evaluations for their surgical protocols.
04
Patients seeking detailed information about the safety and effectiveness of these knee systems.
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People Also Ask about
What is the recovery time for a unicompartmental knee replacement?
People who have a partial knee replacement recover faster than those who have a total knee replacement. Many people are able to walk without a cane or walker within 3 to 4 weeks after surgery. You will need physical therapy for 3 to 4 months.
What is a bicompartmental partial knee replacement?
Bicompartmental knee resurfacing is a less invasive surgical alternative to total knee replacement surgery, where instead of all the compartments being replaced only 2 of the 3 compartments of the knee damaged by arthritis are replaced with a prosthesis.
What is the success rate of unicompartmental knee replacement?
[55] in their meta-analysis, also found comparable survival rates for both medial and lateral UKAs under 10 years (95.8% vs. 96.7%) and over 10 years (92.8% vs. 86.6%). Key articles on survivorship of medial versus lateral unicompartmental knee arthroplasty (UKA).
What is the success rate of unicompartmental knee replacement?
[55] in their meta-analysis, also found comparable survival rates for both medial and lateral UKAs under 10 years (95.8% vs. 96.7%) and over 10 years (92.8% vs. 86.6%). Key articles on survivorship of medial versus lateral unicompartmental knee arthroplasty (UKA).
What is the newest technique for total knee replacement?
Robotic-assisted surgery Using real-time imaging and computer guidance, surgeons now can plan and perform total knee replacement surgery with greater precision, tailored to your exact knee anatomy. This helps ensure better alignment and implant positioning, potentially improving longer-lasting results.
What is the downside of a partial knee replacement?
Con: A partial knee replacement won't last forever Implants are designed to last a long time, but no implant will last forever. Over time, the materials gradually wear out.
What is the unicompartmental approach to knee replacement?
In unicompartmental knee replacement (also called partial knee replacement) only a portion of the knee is resurfaced. This procedure is an alternative to total knee replacement for patients whose disease is limited to just one area of the knee.
What is the history of unicompartmental knee arthroplasty?
Modern UKR implants really started with Marmor, who introduced his modular hemiarthroplasty in 1972 and in 1979 reported a high success rate in 56 patients followed up for a minimum four-year period (6). This was also the period in which the St. Georg sled was introduced in Germany, and in 1976 Engelbrecht et al.
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What is Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments?
The Summary of Safety and Effectiveness for Unicompartmental and Bicompartmental Knee System Instruments is a regulatory document that compiles data pertaining to the safety, effectiveness, and clinical performance of the knee system instruments, ensuring they meet health standards for patient use.
Who is required to file Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments?
Manufacturers of Unicompartmental and Bicompartmental Knee System Instruments are required to file the Summary of Safety and Effectiveness as part of the regulatory submissions to demonstrate compliance with health regulations.
How to fill out Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments?
To fill out the Summary of Safety and Effectiveness, manufacturers must compile relevant clinical data, including design specifications, materials used, preclinical and clinical study results, and risk assessments, followed by submission to the appropriate regulatory body.
What is the purpose of Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments?
The purpose of the Summary of Safety and Effectiveness is to provide evidence of the instrument's safety and efficacy in clinical settings, ensuring that any new products meet regulatory standards and can be safely used in surgical procedures.
What information must be reported on Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments?
The summary must report information such as product description, indications for use, contraindications, clinical study results, adverse events, and comparisons with existing devices, demonstrating the new instrument's safety and effectiveness.
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