Osteosynthesis Screws Ø1.2 - Titamed - Delynov (Quantity per pack of 3 screws)

What is the Titamed Ø1.2 osteosynthesis screw?

The Ø1.2 osteosynthesis screw developed by Titamed is a high-precision micro-fixation device intended for complex surgical interventions. Marketed in packs of 3 units, this small-diameter screw is specifically adapted to the needs of fine stabilization in maxillofacial surgery. This medical device meets the rigorous requirements of the GBR (Guided Bone Regeneration) category to ensure stable mechanical fixation. As a graft fixation screw, it allows for the securing of bone blocks or filling materials to the recipient site, thus guaranteeing the immobility essential to the bone healing process under the constraints of surrounding soft tissues.

What are the clinical indications for this device?

The intended use for these Titamed instruments concerns exclusively craniofacial and maxillofacial surgeries. In clinical practice, the 1.2 mm diameter titanium osteosynthesis screw is indicated for the fixation of autologous bone grafts or bone substitutes, as well as for the maintenance of meshes or regeneration membranes. It is particularly requested during procedures for the reconstruction of atrophied alveolar ridges or the filling of significant bone defects. Its application helps prevent any micromovement of the graft, a critical factor in the failure of bone integration, by offering controlled compression between the graft and the basal bone in anatomical areas requiring low-profile instrumentation.

What are the technical characteristics of this material?

The Titamed Ø1.2 osteosynthesis screw is distinguished by its design optimized for anchoring in cortical and cancellous bone. Although specific material details are not provided in the summary technical sheet, this type of graft fixation screw is designed to offer high mechanical resistance despite its small diameter. The thread geometry is studied to maximize primary stability from insertion. This device is delivered in packaging of 3 screws, allowing the practitioner to have the necessary material for multi-point fixations, often required to stabilize bone blocks in a three-dimensional manner. Each component is subject to strict quality controls to meet the needs of expert oral surgery.

What are the contraindications for the use of these screws?

According to information from the manufacturer Titamed BV, the use of these instruments is strictly reserved for qualified healthcare professionals. General contraindications related to osteosynthesis surgery apply, particularly in the presence of active infections at the surgical site or uncontrolled systemic pathologies compromising vascularization and bone healing. It is imperative to consult the attached instructions for use to identify specific patient-related contraindications, such as known allergies to metallic components or insufficient bone densities that do not allow for satisfactory primary stability. Compliance with the surgical protocol and preoperative evaluation of bone quality are essential to avoid fixation failure.

What are the precautions for use and follow-up for these non-resorbable screws?

As a metallic osteosynthesis device, this graft fixation screw is not resorbable by the body. It requires regular clinical and radiological monitoring to ensure the absence of migration or adverse tissue reaction. The practitioner must carefully read the instructions to determine if removal of the material is necessary after bone consolidation or if the screw can remain in place permanently. Precautions include careful handling with instruments adapted to the 1.2 diameter to avoid any deformation of the screw head socket or fracture of the screw body during tightening. This medical device is reserved for healthcare professionals trained in maxillofacial surgery techniques.

Who is the manufacturer and what standards are respected?

These screws are manufactured by Titamed BV, a company located in Kontich, Belgium. The device benefits from rigorous regulatory certification, classified as Class IIb in accordance with European directives on medical devices. It bears the CE0482 marking, guaranteeing its compliance with current safety and performance requirements. Traceability and manufacturing quality are ensured by Titamed, a recognized manufacturer in the field of implants and instrumentation for craniofacial surgery. Healthcare professionals must systematically refer to the instructions for use provided by the manufacturer to guarantee use in accordance with the safety and clinical efficacy standards expected for this type of surgical equipment.

State of the art

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