Titanium surgical cross-head screw, Ø 1.2 mm, length 10 mm, grey anodized - Helmut Zepf (47.574.10) - Delynov
The Vis cruciforme chirurgicale en titane, diamètre 1,2 mm, longueur 10 mm, anodisée gris - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.574.10.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 47.574.10 surgical cruciform screw?
The Helmut Zepf surgical cruciform screw, reference 47.574.10, is a high-precision bone fixation device used in oral and implant surgery. Manufactured in titanium, it features a diameter of 1.2 mm and a total length of 10 mm. Its structure is characterized by a cruciform recessed head allowing for efficient torque transmission during insertion. The gray anodization of the surface not only facilitates diameter identification within a surgical kit but also reinforces the material's biocompatibility properties. This component is specifically designed to meet primary stability requirements during pre-implant bone reconstruction phases.
What are the clinical indications for this osteosynthesis screw?
This 1 2mm osteosynthesis screw is primarily indicated for the fixation of bone grafts (autologous or allogenic) and non-resorbable membranes during guided bone regeneration (GBR) surgeries. In implantology, it is used to stabilize bone blocks harvested from the donor site and fixed to the recipient site to increase horizontal or vertical alveolar volume. Its use is crucial to prevent any micromovement of the graft, a sine qua non condition for optimal revascularization and successful bone integration. It also plays a role in maintaining space-maintaining devices during the filling of complex bone defects.
What are the technical characteristics of this device?
The 47.574.10 model from Helmut Zepf is distinguished by rigorous technical specifications. Its 10 mm length allows for deep anchorage in cortical and cancellous bone, ensuring superior mechanical retention. The 1.2 mm diameter is a standard in light maxillofacial surgery, offering an ideal compromise between fracture resistance and low biological footprint. The cruciform head design ensures connection stability with the dedicated screwdriver, reducing the risk of slippage during screwing. The titanium used guarantees excellent corrosion resistance and total biological neutrality, avoiding undesirable inflammatory reactions in the surrounding soft and hard tissues.
What are the contraindications for the use of this titanium screw?
Contraindications for the use of this surgical screw primarily include known allergies to titanium or its alloys, although such sensitivities are extremely rare. Clinically, use is discouraged in areas presenting an active uncontrolled infection or insufficient vascularization of the operative site. Unstabilized systemic pathologies affecting bone metabolism, such as severe osteoporosis or certain high-dose bisphosphonate treatments, can compromise the mechanical hold of the screw and the success of the graft. 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 bone site.
What precautions are related to the non-resorbable nature of titanium?
Being manufactured in titanium, this screw is a non-resorbable device. It is designed to remain in place throughout the healing and consolidation phase of the bone graft, which generally lasts several months. Depending on the treatment plan established by the surgeon, the screw can be removed during a second intervention, often at the time of implant placement, or left in situ if it does not interfere with the implant positioning or the final prosthesis. During handling, it is imperative to use compatible instruments (appropriate holders and cruciform screwdrivers) to avoid any ferrous contamination or deformation of the screw head, which could complicate its subsequent removal.
Who is the manufacturer and what are the quality guarantees?
The official manufacturer of this device is Helmut Zepf Medizintechnik GmbH, a German company recognized for its expertise in the design of dental microsurgery instruments and devices. German manufacturing ensures compliance with strict production protocols and the use of high-purity medical-grade materials. Although specific details of the CE marking or regulatory class are not explicitly listed here, Helmut Zepf products are developed according to international quality standards for medical devices. For any precise information on certifications and MDR compliance, it is recommended to refer to the instructions for use provided with the product or to contact the manufacturer directly.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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