10pc pack of Meisinger Tungsten Carbide TCT09 013 Burs (36TCT09013) - Delynov
The x10 vis 0.9 x 13mm (TCT09 013) - Meisinger - 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: 36TCT09013.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Meisinger 0.9 x 13mm osteosynthesis screw?
The 0.9mm osteosynthesis screw (reference 36TCT09013) is a precision medical device manufactured by Hager & Meisinger GmbH. Designed in grade 5 titanium alloy, this screw is specifically dedicated to the fixation of bone grafts in the context of pre-implantological reconstructive surgery. Its structure is distinguished by a Torx connection that ensures optimal retention in the driving tool, thus allowing the transmission of high traction forces without risk of slipping. Its design includes a low-profile screw head, optimizing patient comfort while facilitating the practitioner's work during the placement of guided bone regeneration (GBR) material.
What are the clinical indications for this device?
This Meisinger brand device is indicated for the universal fixation of various types of autologous grafts. It is used to stabilize bone cylinders, bone blocks, or external bone walls during bone augmentation procedures. These interventions can be horizontal, vertical, or three-dimensional, aiming to restore the bone volume necessary before implant placement. The use of this 0.9mm osteosynthesis screw is therefore central to Bone Management® protocols to guarantee strict immobilization of the transplant, a sine qua non condition for successful bone integration and the primary stability of the future implant site.
What are the technical characteristics of the TCT09 013 screw?
The Meisinger TCT09 013 screw has a core diameter of 0.9 mm and a total length of 13.0 mm. It is manufactured from titanium grade 5, a material recognized for its biocompatibility and mechanical strength in surgical environments. One of its major technical characteristics is its Torx socket, which allows a secure connection with the placement instruments, preventing accidental dislodgement of the screw during the procedure. The manufacturer specifies that for each 0.9 mm diameter, there are rescue screws of a larger diameter (TCT10) in the complete sets, to be used if the tensile strength is insufficient during the initial fixation of the bone transplant.
What are the contraindications for using these titanium screws?
The use of these osteosynthesis screws is contraindicated in the presence of active infections localized in the intended implantation area. Systemically, the manufacturer Hager & Meisinger GmbH emphasizes that pathologies or medical treatments resulting in progressive deterioration of bone quality constitute major contraindications. This includes, in particular, non-stabilized metabolic diseases, uncontrolled diabetes, or the intake of specific medical treatments such as long-term corticosteroids, immunosuppressants, or bisphosphonates. As with any oral surgery procedure, the usual general and local medical contraindications must be strictly respected by the surgeon.
What are the precautions for use and handling?
To ensure correct and safe use, the practitioner must strictly follow the recommended and maximum rotation speeds indicated by the manufacturer in the instrument overview. Precise handling is required to preserve the integrity of the titanium alloy and ensure the stability of the fixation. Although the diameter is reduced for clinical comfort, the screw allows for the transmission of significant forces thanks to its Torx profile. It is essential to ensure that the transplant is fixed with sufficient tensile strength; otherwise, switching to a larger diameter screw (rescue screw) may be necessary to secure the bone augmentation.
Who is the manufacturer and what standards are met?
This device is manufactured by Hager & Meisinger GmbH, located in Neuss, Germany. This product belongs to the Class IIb medical device category, meeting strict regulatory requirements for surgical implants. It carries the CE0044 marking, certifying its compliance with current European standards. As part of the Screw System TX and Screw System TX Professional systems of the Bone Management® line, this screw is subject to rigorous quality controls to guarantee its clinical performance in autologous bone graft fixation procedures in implant surgery.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Meisinger |
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