NAVISURG ReduClamp™ Linear

Product Information

• Product name: NAVISURG ReduClamp™ Linear
• Device Owner / Brand Owner: NOVAMED GLOBAL JOINT STOCK COMPANY
• Country of Origin: Vietnam
• Indications: Used to assist in the reduction and temporary stabilization of fractured bone fragments in orthopedic surgery, particularly in minimally invasive techniques.

Product Description

• The ReduClamp™ Linear consists of: The bone reduction clamp consists of a central sliding mechanism, detachable clamp arms, and reduction assistance accessories.
• The design allows a precise, continuous, and controlled reduction force.
• The clamp arms can be mounted in multiple positions, making the device suitable for various fracture patterns.
• Material: High-quality biomedical metal with high mechanical strength, suitable for sterilization and repeated reuse.

Indications for Use

The device is used to:

• Reduce and temporarily stabilize fractured bone fragments.
• Support minimally invasive surgical treatment of: Long bone fractures, periarticular fractures, and pelvic fractures.
• Maintain reduction during placement of plates, screws, or definitive internal fixation systems.

Contraindications

Not intended for use in the following cases:

• Severely osteoporotic or brittle bone is unable to withstand clamping force.
• Severe soft tissue injury at the clamping site.
• Situations requiring long-term bone fixation without additional fixation devices.

Intended Users

• Orthopedic surgeons
• Trained healthcare professionals
• Environment of use: Operating rooms meeting sterile surgical standards

Product Advantages

• Provides precise reduction with controlled force.
• Maintains temporary fracture stability throughout the surgical procedure.
• Suitable for minimally invasive surgical techniques.
• Flexible and adaptable to various fracture types.
• Reduces reliance on manual manipulation.
• Effectively compatible with other bone fixation systems.

Instructions for Use

Summary of use procedure:

• Select clamp arms appropriate for the fracture type.
• Attach the clamp arms to the central sliding mechanism.
• Position the device at the reduction site.
• Gradually apply the reduction force until the desired alignment is achieved.
• Maintain temporary stabilization while definitive bone fixation is performed.
• Remove the device after fixation is completed.

Storage & Sterilization

• Medical-grade metal, durable, safe, and compatible with steam sterilization.
• Store in a clean, dry environment; avoid corrosion and impact.
• Inspect the device condition before each use.

Warnings

• For use only by trained healthcare professionals.
• Do not apply excessive clamping force that may cause bone or soft tissue injury.
• Do not use if the device shows signs of damage or deformation.
• Intended only for reduction and temporary stabilization, it does not replace definitive bone fixation.