Self-drilling ROGFIXE Micro-screws 3 to 5 mm (Pack of 10) - Titamed

What is the Titamed ROGFIXE self-drilling micro-screw?

The ROGFIXE micro-screw from the Titamed brand is a specialized fixation device for guided bone regeneration (GBR). Designed by Titamed BV, this micro-screw is distinguished by its self-drilling property, facilitating its insertion during surgical procedures. Packaged in lots of 10 units, it features dimensions ranging between 3 to 5 mm. This high-precision equipment is specifically developed to meet the requirements of surgeons performing complex bone reconstructions. As a Class IIb medical device, it meets strict safety and performance standards to guarantee optimal stability when fixing membranes or bone grafts in the maxillofacial area.

What are the clinical indications for these micro-screws?

ROGFIXE micro-screws manufactured by Titamed BV are intended exclusively for professional use. According to the manufacturer's indications, these instruments are intended to be used during craniofacial and maxillofacial surgeries. They are primarily used in bone regeneration protocols where rigid fixation is necessary to maintain the stability of graft materials or protective barriers. Their self-drilling design allows for efficient application in the bone, potentially reducing operative time during stabilization phases. It is imperative for the practitioner to carefully read the instructions for use before any intervention to ensure application in accordance with established clinical protocols.

What are the technical characteristics of the ROGFIXE range?

The ROGFIXE range from Titamed is characterized by micro-screws 3 to 5 mm in length, designed to provide a reliable grip in bone tissue. The major specificity lies in their self-drilling capacity, meaning they are developed to penetrate bone without systematically requiring prior pre-drilling, depending on the bone density encountered. This device is certified according to the CE0482 marking, attesting to its compliance with European regulatory requirements for Class IIb implantable medical devices. Each lot contains 10 micro-screws, allowing for precise stock management for practices specialized in oral surgery and implantology.

What are the contraindications for the use of this device?

The use of ROGFIXE micro-screws must be strictly limited to the indications provided by Titamed BV, namely cranio- and maxillofacial surgery. Although specific contraindications are not detailed in the summary data, the use of this medical device is reserved exclusively for qualified healthcare professionals. It is contraindicated to use these instruments outside the defined surgical framework or by untrained personnel. As with any bone fixation implant, the practitioner must evaluate individual patient risk factors, such as insufficient bone quality or systemic pathologies that could compromise osseointegration or the mechanical stability of the screw.

What are the precautions for use for Titamed micro-screws?

Handling Titamed ROGFIXE micro-screws requires particular attention. As a Class IIb medical device, their use is strictly reserved for healthcare professionals. Before any use, it is essential to carefully read the manual provided by the manufacturer Titamed BV. Precautions include checking the integrity of the packaging and the sterility of the product before the surgical act. The practitioner must ensure that the associated instruments are compatible with the ROGFIXE system to avoid any damage during insertion. Rigorous preoperative planning is necessary to choose the appropriate screw length (between 3 and 5 mm) based on the patient's anatomy and the thickness of the recipient site.

Who is the manufacturer and what standards are respected?

The official manufacturer of this device is the company Titamed BV, located in Kontich, Belgium. ROGFIXE micro-screws benefit from the CE0482 marking, guaranteeing compliance with current European standards for medical devices. This product is classified as Class IIb according to MDR regulations, which highlights its high level of control and safety for long-term invasive interventions. Titamed BV ensures the traceability and manufacturing quality of these instruments intended for specialized surgery. Compliance with these strict standards provides dental surgeons and implantologists with reliable equipment for their maxillofacial reconstruction procedures.

State of the art

Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.