A FDA 510(k) approval for “Vertaux 5.5 mm Pedicle Screw System”, a system intended for posterior, non-cervical fixation has been granted to India’s leading orthopedic brand Auxein Medical Pvt. Ltd. on 6th April 2021.
Auxein’s Vertaux 5.5mm Pedical screw system consists of Mono-Axial Pedicle Screw, Poly-Axial Pedicle Screw, Pedicle Screw Cap, VERTAUX Pedicle Screw Cap, VERTAUX Crosslink-I, VERTAUX Crosslink-II, VERTAUX Rod. This system comes with a wide range of rods, connectors and screws, which combine to provide the best spine implantation possible for the treatment of deformity and other requirements.
The Pedicle screw system and the instrument set provides the proficient features for easy handling and introduction of the device into the spinal system, like the VERTAUX Mono-axial Pedicle Screw is threaded and the head is fixed for top loading for an easy rod introduction, VERTAUX Poly-axial Pedicle Screw has 60° rotational freedom for easier rod placement and reduction, even when the screws are not perfectly aligned with one another. VERTAUX-Pedicle Screws Cap used to apply the pressure to hold the rod inside the U-Part head, its buttress threads reduce profile and improves cross-threading resistance & the internal set screw allows for placement and visualization., Vertaux Crosslink I & II is used for connecting two vertaux rods providing a rigid and stable spine construct, with the only difference that the cross link II has assembly parts which are assembled during surgery and finally the VERTAUX-Pedicle Rod is made to easily contour the individual patients anatomy using titanium alloy. Further user-friendly feature are the colour-coded screws according to size which further reduces the complexiety for the OR technician.
The International Sales Director Mr Rahul Luthra takes immense pleasure & pride in manufacturing a world-class quality product, produced in-house in India and marketed globally across many countries. he adds that “This product marks a crucial milestone in the development and progress of Auxein, as it progresses towards creating an impact around the world in the race of quality implants”.
Auxien is now ramping up its way towards the commercial release of VERTAUX Mono-axial Pedicle Screw in United States of Ameria after its success in Europe, Asia-Pacific and Latin America. VERTAUX Mono-axial Pedicle Screw is a CE-certified product.
Indications for Use:
* Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis and/orlordosis); Tumor and pseudarthrosis.
About Auxein Medical Pvt. Ltd Auxein Medical is an integrated, research based, orthopaedic Implants & Instruments manufacturing company, producing a wide range of quality, affordable generic implants, trusted by healthcare professionals and patients across geographies. It is the Company’s constant endeavor to provide a wide basket of generic and innovator products that exceed the highest expectations of our customers in term of quality and safety.Auxein is india’s first MDSAP certified from BSI, UK in the orthopedic section and also having CE certification from the european notified bodies DNV, Norway and DQS, Germany.
The company has a world-class manufacturing unit established in India and serves customers in over 60 countries worldwide.