BackNAVISURG SutureDrive™ Handle is engineered to provide precise and reproducible graft tension control in ACL and PCL reconstruction procedures. The system enables accurate adjustment, maintenance, and monitoring of suture tension throughout fixation. Designed for use with bone tunnels, suspension systems, and minimally invasive techniques, it ensures stable graft positioning. Supporting consistent tension across the full range of joint motion, it enhances surgical accuracy and reliability. Its user-friendly design helps optimize operative efficiency and contributes to improved postoperative outcomes.
Product Information
- Product Name: NAVISURG SutureDrive™ Handle
- Device Owner / Brand Owner: NOVAMED GLOBAL JOINT STOCK COMPANY
- Country of Origin: Vietnam
- Indications: To assist in tensioning and controlling graft sutures in anterior and posterior cruciate ligament reconstruction (ACL/PCL), helping to achieve stable and reproducible graft tension during surgery.
Product Description
- The SutureDrive™ Handle is designed to support precise graft suture tensioning in ligament reconstruction surgery.
- The system allows adjustment and maintenance of graft tension during fixation and enables measurement and monitoring of tension throughout the surgical procedure.
- The device can be used in various surgical techniques, including ligament reconstruction through bone tunnels and graft fixation using suspension buttons or suture posts.
Indications for Use
- Anterior Cruciate Ligament (ACL) reconstruction surgery
- Posterior Cruciate Ligament (PCL) reconstruction surgery
- Graft suture tensioning in ligament reconstruction techniques using bone tunnels or minimally invasive techniques
Contraindications
- Not indicated in cases where graft suture tension control or measurement is not required
- Not intended for use for purposes outside orthopedic and sports medicine surgery
Intended Users
- Orthopedic and sports medicine surgeons
- Trained healthcare professionals
- Environment of use: Operating rooms meeting sterile surgical standards
Product Advantages
- Allows precise and reproducible control of graft tension
- Helps maintain stable graft tension during fixation
- Supports assessment of graft tension throughout the full range of joint motion
- User-friendly design with easy handling, helping to reduce surgical time
- Reduces the risk of uneven graft tension, contributing to improved postoperative outcomes
Instructions for Use
Summary of use procedure:
- Prepare the graft and sutures according to the surgical technique
- Attach the graft sutures to the tensioning device and secure them in the appropriate position (bone tunnel or suspension system)
- Adjust the tension using the device mechanism until the desired level is achieved
- Check graft tension while moving the joint through its range of motion
- Fix the graft and remove the device according to the standard procedure
Storage & Sterilization
- Clean and sterilize the device before first use and after each reuse
- Sterilization method: Steam sterilization or as recommended by the manufacturer
- Store in a clean, dry place; avoid impact and corrosion
Warnings
- For use only by physicians and healthcare professionals with appropriate training
- Do not apply tension beyond recommended limits to avoid damage to the graft
- Inspect the device before use; do not use it if there are signs of damage or deformation
