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The ORIGO system is a software-controlled motorized system that includes attachments and tools for cutting soft tissue and bone and provides irrigation fluid to the surgical site. The ORIGO system is used in the following surgical fields: · for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries.

The ORIGO System is a software-controlled electrically-powered surgical system designed to be used in an operating room by a clinician for head & neck, ENT, and maxillofacial surgical procedures in a healthcare facility/hospital setting. The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible micromotors and motorized handpieces with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories. The ORIGO System transforms electrical energy through micromotors or motorized handpieces and converts it to rotational force to cut bones and resect soft and hard tissues through attached cutting tools. Four motor subsystems of the ORIGO System include NANO, RAPIDO, OSSEOSTAP, and S120. The NANO and RAPIDO are micromotors. OSSEOSTAP is a motorized microdrill handpiece. S120 is a motorized shaver handpiece that is a microdebrider/microresector. PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor and used in conjunction with PM2 Burs. The PM2 80K Burs and PM2 50K Burs are used for cutting and shaping bones in ENT surgical procedures. OSSEPSTAP is intended to be used for cutting and shaping bones in ENT surgical procedures, such as stapedotomy or ossiculoplasty. The OSSEOSTAP is used with OSSEOSTAP Burs and OSSEOSTAP Perforator. S120 is intended to be used for resecting soft and hard tissues in ENT surgical procedures. The S120 is used with S120 Shaver Blades and S120 Shaver Burs. The ORIGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORIGO System Irrigation Line. The ORIGO System is a prescription-only device.

The ORiGO System is a software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site. The ORiGO System is used in the following surgical fields: -For cutting bones in neuro (cranial) and spinal surgeries.

The ORIGO System is a software-controlled electrical surgery system intended to be used in an operating room by a clinician in a healthcare facility/hospital setting for cranial and spinal surgical procedures. The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible two micromotors and one motorized handpiece with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories. The ORIGO System transforms electrical energy through motors and converts it to rotational force to shape and cut bones through attached cutting tools. Three micromotor subsystems of the ORIGO System include NANO, RAPIDO, and PM PERFO. The NANO and RAPIDO are micromotors. The PM PERFO is a motorized cranial perforator handpiece. PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor. Cranio-Guards are attached to the PM2 Handpieces, and craniotomy is performed using PM2 Craniotomy Burs. Other PM2 80K Burs are attached to the PM2 Handpieces without attachment. The PM2 80K Burs are used for cutting bones in cranial and spinal surgical procedures. PM PERFO is intended to be used for a cranial perforation. The ORiGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORiGO System Irrigation Line. The ORiGO System is a prescription-only device.

The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.

The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.

The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The OSSEOSTAP system has been designed for use by medical professionals for the light drilling of bone as part of surgical ENT otology procedures, such as stapedotomy or ossiculoplasty.

The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.

The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery. The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue in the fields of: - Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) - Endoscopic dacryocystorhinostomy (DCR) - Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy) - Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery) The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery).

The OSSEODUO Shaver and Drill System consists of a control unit, a footswitch, connection cables, a shaver handpiece (also named microdebrider or microresector) to drive various shaver blades, a drill motor and assorted handpieces to drive various burs, drills, rasps and micro saw. The control unit consists of a closed box with, on its main side, an LCD display screen and various function keys allowing the device to be adjusted according to the planned operation. On the right-hand side of the control unit are the connectors for the shaver handpiece S80 and for the micromotor 80K, while the pedal is connected on the rear panel. A peristaltic pump for irrigation and cooling is mounted on the rear panel which also contains the main power-up switch and the fuse holder. The shaver handpiece includes a micromotor, a gear set, a coupling system for shaver blades and connections for irrigation. Through the control unit it can operate in oscillating modus (reversing after a user-defined number of turns in each direction) or in continuous CW and CCW rotation. Its made of stainless steel and autoclavable. The shaver handpiece is available in two version: the S80 being the basic model and the 5120 with higher rotation speed (up to 12'000 rpm in continuous rotation) and the ability to orient the shaver blade during operation without releasing the chucking mechanism. The micromotor 80K has an ISO 3964 type E standard coupling which connects to a broad range of different handpieces, such as drill, contra-angle, saw, etc. Through the control unit it can achieve speeds of up to 80'000 rpm. All outer surfaces are made of stainless steel and the motor is autoclavable. The footswitch allow a smooth progressive and continuous command of the shaver or drill speed. It is IPX8 waterproof.