In craniomaxillofacial (CMF) surgery, precision, stability, and biocompatibility are paramount. A well-designed CMF self-drilling screw pack has a direct impact on surgical outcomes, reduces operating time, and enhances patient recovery. However, not all screw packs are created equal. To ensure you select a product that meets the highest performance standards, consider these five critical criteria:
1. Material Requirements – The Strength and Biocompatibility Factor
The foundation of any CMF self-drilling screw pack lies in its material composition. High-quality CMF screws are typically manufactured from Ti-6Al-4V titanium alloy. This grade of titanium is widely recognized in the medical field for its exceptional strength-to-weight ratio, corrosion resistance, and, most importantly, its excellent biocompatibility.
Compared with stainless steel, Ti-6Al-4V not only minimizes the risk of allergic reactions but also promotes long-term bone integration. In CMF procedures, where screws are often placed in delicate cranial and facial bones, this biocompatibility ensures reduced inflammatory response and enhanced healing. Always check material certificates from the manufacturer to confirm the alloy grade and its compliance with ASTM F136 or ISO 5832-3 standards.
2. Screw Size Range – Adaptability and Surgical Flexibility
A high-performance CMF self-drilling screw pack should offer a variety of screw diameters and lengths to accommodate different surgical needs. For example, shorter screws (4–6 mm) are often used in thin cortical bone areas, while longer screws (up to 14 mm) may be necessary for thicker bone or complex reconstructive cases.
Flexibility in screw sizing reduces the need for multiple product sources and minimizes surgical delays. An ideal pack should be clearly labeled with size indicators, enabling surgeons to select the right screw quickly without disrupting workflow. In addition, the screw design should ensure consistent self-drilling capability, reducing the need for pre-drilling in most cases, which can save precious time in the operating room.
3. Surface Treatment – Enhancing Bone Integration and Performance
The surface finish of CMF screws plays a critical role in both mechanical performance and biological response. High-grade CMF self-drilling screw packs often feature anodized or polished surfaces.
Anodization increases surface oxide thickness, improving corrosion resistance and enhancing osteointegration by creating a bioactive surface that encourages bone cell attachment.
Polishing minimizes microscopic irregularities, reducing bacterial adhesion and lowering the risk of post-operative infection.
Some advanced products may combine surface roughening for initial stability with anodization for long-term biocompatibility. When evaluating a screw pack, review the manufacturer’s surface treatment specifications and any available clinical test data.
4. Sterile Packaging – Compliance with Operating Room Standards
Even the highest-quality screw is compromised if its packaging fails to meet sterile requirements. A premium CMF self-drilling screw pack should be delivered in individually sealed, sterile, and easy-to-open packaging that aligns with operating room protocols.
Look for packs that feature:
Double sterile barriers for added protection
Clearly marked expiration dates and lot numbers for traceability
User-friendly designs that allow for quick screw retrieval without breaking sterile technique
Some manufacturers also offer ready-to-use sterile trays that organize screws and drivers in a logical sequence, streamlining the surgical process.
5. Regulatory Compliance – CE, FDA, and ISO 13485 Certification
In the medical device industry, certifications are more than paperwork — they are proof of consistent quality and safety. A trusted CMF self-drilling screw pack should meet internationally recognized standards such as:
CE marking – Required for distribution in the European Union, confirming compliance with the EU Medical Device Regulation (MDR).
FDA clearance – Ensures the product meets safety and performance requirements in the United States.
ISO 13485 certification – Demonstrates that the manufacturer’s quality management system is specifically tailored for medical devices.
Purchasing from certified suppliers not only assures product reliability but also reduces legal and compliance risks for hospitals and clinics.
At Shuangyang Medical, we are not only the supplier but also the manufacturer of the 1.5 mm CMF self-drilling screw pack. Designed and produced in-house, our screws are made from premium Ti-6Al-4V medical-grade titanium alloy and crafted using advanced Swiss TONRNOS CNC technology for exceptional precision and consistency. With anodized surface treatment, multiple size options, sterile packaging, and full compliance with CE, FDA, and ISO 13485 standards, our products are built to meet the highest surgical performance requirements.
Partnering with us means working directly with the source — ensuring competitive pricing, stable supply, and uncompromising quality for your CMF surgical needs.
Post time: Aug-11-2025