BackThe NAVISURG KneeForm™ UNI System for the Knee supports the creation of cement spacers that help control infection and maintain temporary joint function during treatment. The set includes both femoral and tibial moulds, engineered from durable, heat-resistant medical-grade alloy for repeated use. Its anatomically accurate design ensures precise and stable handling, optimizing surgical outcomes in knee joint infection cases.
1. Product Information
Product Name: NAVISURG KneeForm™ UNI System
Device Owner / Brand Owner: NOVAMED GLOBAL JOINT STOCK COMPANY
Country of Origin: Vietnam
Indication: Designed for shaping antibiotic-loaded bio-cement spacers to control orthopedic infections and maintain temporary joint function during treatment.
2. Product Description
The product consists of a metal mould set that includes alignment pins, fixation screws, and assembly/disassembly tools.
A knee spacer mould set includes two components:
Femoral mould (condylar component)
Tibial mould (tibial tray component)
It is designed to create antibiotic-loaded bio-cement spacers that replicate the anatomical structures corresponding to the knee joint area requiring treatment.
Material: High-strength medical-grade alloy, heat-resistant and suitable for repeated sterilization.
3. Indications for Use
The bio-cement mould is used for:
Shaping antibiotic-loaded cement spacers for treating knee joint infections following total knee replacement or bone fixation surgery.
Creating local antibiotic cement to:
Control bone and joint infections
Maintain joint space and temporary function during the treatment interval before definitive revision surgery
4. Contraindications
Do not use in the following cases:
Patients with allergies or hypersensitivity to PMMA cement or mixed antibiotics
Severe bone or soft-tissue destruction that prevents anatomical reconstruction
Patients with systemic conditions unsuitable for surgery
5. Intended Users
For use by orthopedic surgeons and trained medical professionals
Intended for sterile operating room environments
6. Product Advantages
Anatomically accurate design, easy to handle
Helps reduce surgical time
Compatible with various medical bone cement formulations and antibiotics
Easy to assemble and disassemble; highly durable; reusable after proper sterilization per guidelines
7. Instructions for Use (Summary)
Prepare PMMA bone cement and antibiotics as prescribed clinically
Mix thoroughly and inject/pour the mixture into the mould
Allow the cement to harden according to the specified setting time
Open the mould, remove the shaped spacer, and proceed with surgical application
8. Sterilization & Storage
Sterilization: Steam sterilization or as recommended by the manufacturer
Store in a dry environment, avoid corrosion and impact
Inspect product before use; do not use if damaged or deformed
9. Warnings
For use by qualified medical professionals only
Do not use if the device is not properly sterilized
Misuse may result in improper spacer shaping, uneven antibiotic distribution, or reduced treatment effectiveness
Strict aseptic technique must be maintained throughout handling