ROGFIXE 3mm titanium micro-screw kit for GBR- Delynov

What is the ROGFIXE 3mm titanium micro-screw kit for GBR - Delynov?

The ROGFIXE 3mm titanium micro-screw kit for GBR marketed by Delynov is a specialized instrumental set designed for Guided Bone Regeneration (GBR) procedures. This medical device from the Titamed brand consists of titanium micro-screws with a specific length of 3mm. The choice of titanium as the primary material ensures excellent biocompatibility and optimal mechanical strength during the fixation of membranes or bone grafts. This complete kit provides practitioners with a reliable solution for stabilizing filling materials during pre-implant or periodontal bone reconstruction surgeries.

What are the clinical indications for the Titamed ROGFIXE kit?

The ROGFIXE kit from Titamed is primarily indicated for use in oral surgery, implantology, and periodontology. Its main use involves the fixation of protective membranes or bone blocks during Guided Bone Regeneration (GBR) protocols. The 3mm micro-screws ensure rigid primary stability of the graft material, a prerequisite for successful osseointegration and bone healing without the interposition of fibrous tissue. This device is essential for dental surgeons and maxillofacial surgeons performing complex bone volume augmentations.

What are the technical characteristics of this micro-screw kit?

The technical characteristics of this kit are based on the manufacturing precision of Titamed BV. The kit includes 3mm titanium micro-screws, a dimension suitable for areas where available bone thickness is limited or for the fixation of thin membranes. The design of the screw head and thread is optimized to provide precise insertion and maximum retention in the cortical bone. As a complete kit, it facilitates organization in the operating room by grouping the elements necessary for placing the fixation screws, thus ensuring a fluid working ergonomics for the implantologist.

What are the contraindications for the use of ROGFIXE micro-screws?

Although detailed specifications must be consulted in the Titamed BV manufacturer's instructions for use, general contraindications for this type of titanium device include known allergies to titanium or its alloys. Use is also discouraged in the presence of active infections at the surgical site, uncontrolled systemic pathologies affecting bone metabolism (such as severe osteoporosis or unbalanced diabetes), or in cases of local irradiation. It is the practitioner's responsibility to evaluate the benefit-risk ratio based on the patient's general health status and the quality of the recipient site.

What precautions should be taken for these non-resorbable screws?

The 3mm micro-screws included in the Titamed ROGFIXE kit are made of titanium, a material that is not resorbable by the body. Unlike resorbable devices, these screws maintain permanent mechanical stability until their eventual surgical removal. Precautions for use include controlled tightening to avoid any screw fracture or excessive compression of the cortical bone (ischemia). Adequate tissue coverage by a full-thickness flap is necessary to prevent any post-operative exposure of the screw, which could compromise the success of the bone regeneration.

Who is the manufacturer and what is the regulatory information?

The official manufacturer of this device is Titamed BV, a company recognized for its expertise in the design of osteosynthesis solutions. The ROGFIXE 3mm titanium micro-screw kit is distributed by Delynov. For any information regarding the regulatory class, specific CE marking, or applied ISO compliance standards, healthcare professionals are invited to refer scrupulously to the product labeling and the instruction manual provided by Titamed. This device must be used exclusively by practitioners trained in oral surgery and implantology techniques.

State of the art

Single-use sterile surgical kits significantly reduce intraoperative contamination.