Self-drilling ROGFIXE Micro-screws 3 to 5 mm (Pack of 10) - Titamed
The Micro-vis ROGFIXE autoforante 3 à 5 mm (lot de 10) - Titamed - ROGFIXE is a medical device manufactured by Titamed BV — Class IIb, CE marking CE0482.
- Compliance: Medical device Class IIb, CE marking CE0482.
- Manufacturer: Titamed BV.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the ROGFIXE micro-screw?
The ROGFIXE micro-screw, developed by the manufacturer Titamed, is a precision medical device used in maxillofacial surgery. This lot of 10 units includes screws from 3 to 5 mm, designed to offer optimal primary stability during bone regeneration protocols. As a self-drilling micro screw, it allows direct insertion into the bone, thus simplifying the surgical procedure by limiting the preliminary drilling steps. This device is a key element for maintaining reconstruction structures, ensuring that membranes or grafts remain perfectly immobile during the bone healing phase.
What are the clinical indications for this ROG screw?
The clinical indications for the Titamed self-drilling rog screw primarily concern craniofacial and maxillofacial surgeries. It is recommended for the fixation of protective membranes, whether resorbable or non-resorbable, as well as for the immobilization of small autologous or allogenic bone grafts. Its use is particularly relevant in cases of guided bone regeneration (ROG) where the stability of the reconstructed volume is imperative for the success of tissue integration. This device helps prevent any displacement of the filling material under the soft tissues, thus ensuring predictable and secure regeneration for the patient.
What are the technical characteristics of the ROGFIXE micro-screw?
The Titamed rog micro screw is distinguished by its mechanical properties adapted to the constraints of the maxillary and mandibular bone. Available in lengths from 3 to 5 mm, it features a specific thread profile that gives it its self-drilling properties. This technical characteristic allows precise penetration and a firm grip in the bone cortex. The design of the screw head is optimized to ensure effective maintenance of the membrane without tearing, while remaining discreet enough not to create excessive tension under the mucosal flap during surgical wound closure.
What are the contraindications for the use of this device?
Although the regulatory text does not specify precise medical contraindications for this model, the use of the titanium self-drilling micro screw must be evaluated by the practitioner based on the patient's general health status. Standard contraindications in oral surgery apply, notably uncontrolled systemic pathologies affecting bone metabolism or healing. It is imperative to consult the instructions for use provided by Titamed BV to identify any restrictions related to allergies to metallic components or specific clinical situations where bone density would be insufficient to guarantee the stability of the device.
What are the precautions for use for these non-resorbable screws?
As these are non-resorbable devices, rog micro screws require rigorous planning. They must be handled with adapted instruments to avoid any contamination or damage to the thread. The practitioner must ensure controlled tightening so as not to damage the bone cortex. As indicated in the warnings, this medical device is strictly reserved for healthcare professionals. Particular attention must be paid to the management of surrounding soft tissues to avoid any exposure of the screw during the healing period. The removal of the screw is generally carried out during a second surgical phase, once the regeneration objective is achieved.
Who is the manufacturer and what standards are respected?
The ROGFIXE micro-screw is manufactured by Titamed BV, a company based in Belgium in Kontich. This medical device belongs to Class IIb, meeting strict safety and performance requirements for surgical implants. It benefits from the CE0482 marking, attesting to its compliance with current European standards. The traceability and manufacturing quality of Titamed ensure dental surgeons and implantologists a reliable material for their complex interventions. Users are reminded to read the instructions carefully and respect the sterilization and use protocols recommended by the manufacturer to guarantee patient safety.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Length | 3mm, 4mm, 5mm |
| Our selection | The Delynov Choice |
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