TX Basic Screwdriver System - Meisinger - Hager & Meisinger GmbH (79BTX00) - Delynov
The Système de vissage TX Basic - Meisinger - Hager & Meisinger GmbH() is a medical device manufactured by Hager & Meisinger GmbH — Class IIb, CE marking CE0044.
- Compliance: Medical device Class IIb, CE marking CE0044.
- Manufacturer: Hager & Meisinger GmbH.
- Reference: 79BTX00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Meisinger TX Basic screw system?
The TX Basic screw system, referenced under code 79BTX00 by the manufacturer Hager & Meisinger GmbH, is a Class IIb medical device dedicated to osteosynthesis in oral surgery. This kit primarily consists of dental osteosynthesis screws made of Grade 5 titanium alloy, a material recognized for its biocompatibility and mechanical strength. The screw structure integrates a specific Torx socket, designed to guarantee secure retention in the driving tool while allowing the transmission of significant tensile forces without the risk of slipping. This compact system is optimized to offer easy handling for the practitioner while minimizing bulk for patient comfort thanks to a low screw head height.
What are the clinical indications for this screw kit?
The Meisinger Screw System TX is indicated for the universal fixation of various types of autologous bone grafts. Dental surgeons and implantologists specifically use it to stabilize cylindrical grafts, bone blocks, or external bone walls (lamellae). These procedures generally occur within the framework of pre-implantological bone augmentations, whether horizontal, vertical, or three-dimensional. The clinical objective is to ensure strict immobilization of the bone transplant against the recipient site to promote the osseointegration required before the final placement of implants. The system adapts to different anatomical configurations encountered during complex alveolar reconstructions.
What are the technical characteristics of the TX Basic system?
The TX Basic system is distinguished by the use of Grade 5 titanium screws with a standard core diameter of 0.9 mm (reference TCT09). An essential technical feature of this dental surgery screw kit is the inclusion of a "rescue" screw (reference TCT10) featuring a wider diameter. This specific screw is intended for situations where the transplant cannot be fixed with sufficient tensile strength using the standard screw. The Torx interface ensures a stable connection between the screw and the screwdriver, reducing the risk of losing the implant during transfer to the surgical site. The manufacturer Hager & Meisinger GmbH specifies that the rotation speeds indicated in the technical documentation must be strictly observed to guarantee the safety of the device.
What are the contraindications for the use of this osteosynthesis system?
The use of the Screw System TX is subject to compliance with general and local medical contraindications specific to oral surgery. Absolute contraindications include the presence of active infections in the area planned for implantation. Furthermore, the system must not be used in patients suffering from serious systemic or metabolic diseases, or receiving medical treatments leading to progressive deterioration of bone mass. Explicitly cited are treatments with cortisone, immunosuppressants, bisphosphonates, as well as uncontrolled diabetes. The practitioner must carefully evaluate the benefit-risk ratio based on the patient's overall health status and bone regeneration capacity.
What precautions should be taken when using titanium screws?
Although Grade 5 titanium screws are non-resorbable, their placement requires precise precautions to ensure the success of the bone augmentation. The user must ensure compliance with the maximum rotation speeds recommended by Meisinger to avoid any thermal heating of the bone, which could compromise graft integration. The low screw head height is designed to reduce soft tissue irritation, but adequate mucosal coverage without tension remains imperative. In case of insufficient resistance during initial screwing, an immediate switch to the TCT10 rescue screw is recommended to guarantee the primary stability essential for the survival of the autologous bone block.
Who is the manufacturer and what standards are met?
The TX Basic screw system is manufactured by Hager & Meisinger GmbH, a company based in Neuss, Germany. This medical device is certified compliant with European regulatory requirements with a CE0044 marking. It is classified as Class IIb according to the Medical Device Regulations (MDR). As a product of the Bone Management® line, this system benefits from the expertise of a manufacturer recognized for the precision of its rotary and surgical instruments. Compliance with these strict standards guarantees healthcare professionals reliable, traceable equipment specifically designed for the requirements of modern implant surgery, thereby ensuring optimal safety for the patient and the user.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Meisinger |
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