BackThe NAVISURG Hipspacer™ System offers an effective solution for creating antibiotic-loaded cement spacers used in two-stage treatment protocols for infected hip joints. Designed with anatomical accuracy and a robust metal mould system, it allows surgeons to work more quickly, precisely, and consistently in the operating room. Its durable, easy-to-assemble structure and compatibility with sterile surgical environments make it an optimal choice for orthopedic specialists.
1. Product Information
Product Name: NAVISURG Hipspacer™ 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 bone and joint infections and to maintain temporary joint function during treatment.
2. Product Description
The product includes a metal mould set, along with pins, fixation screws, and tools for stabilizing the hip joint frame.
It is engineered to form antibiotic-loaded bio-cement spacers, replicating the anatomical structure of the hip joint to maintain temporary function during 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:
Forming antibiotic-loaded cement spacers for the treatment of hip joint infections following joint replacement surgery or bone fixation procedures.
Creating local antibiotic cement to:
Control bone and hip joint infections
Maintain joint space and temporary function during the interim period before definitive surgery
4. Contraindications
Do not use in the following cases:
Patients with known allergies or hypersensitivity to PMMA cement or the mixed antibiotics
Severe bone or soft-tissue destruction that prevents anatomical reconstruction
Patients with systemic conditions that contraindicate surgery
5. Intended Users
Designed for orthopedic surgeons and trained medical professionals
Intended for use in sterile, accredited operating room environments
6. Product Advantages
Anatomically accurate design for easy manipulation
Reduces surgical time
Compatible with various medical cement types and antibiotic formulations
Easy to assemble/disassemble; high durability; reusable after proper sterilization following manufacturer guidelines
7. Instructions for Use (Summary)
Prepare PMMA bone cement and antibiotics according to clinical requirements
Mix thoroughly and pour the mixture into the mould
Allow the cement to harden as per the recommended setting time
Open the mould, remove the shaped spacer, and proceed with surgical implantation
8. Sterilization & Storage
Sterilization: Steam sterilization or according to manufacturer recommendations
Store in a dry area, avoid corrosion and impact
Inspect the 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 has not been sterilized properly
Incorrect use may result in improper shaping, uneven antibiotic distribution, or reduced treatment effectiveness
Strict aseptic techniques must be followed during all handling steps