We are pleased to announce the cl earance of 51 0(k) by United States Food and Drug Administration (US FDA) for our two Pedicle Screw System(s) – 4CIS SARA SPINE SYSTEM and 4CIS VERTU SPINE SYSTEM.
Launched in 2017, 4CIS Sara Spine is a Cortical- Cancellous Pedicle Screw System. Screws of 4CIS Sara Spine.– QUAD LEAD Pedicle Screw System is designed to achieve greater cortical bone purchase with a smaller midline incision when utilized in a medial to lateral pedicle approach known as the Cortical Bone Trajectory (CBT). The Self-centering,Self-tapping conical tip with threads that extend to the distal tip of t he screw, allows for immediate bone engagement, reliable insertion, and accurate control. The Dual to Quad lead threads double the number o f screw-to-bone contact points within the pedicle thereby increasing resistance to pull out.
4CISVERTUSpineS ystem is a dual lead pedicle screw system.Dual lead thread al lows screw to be inserted twice as fast (with half as many rotations) as a single lead screw, which may potentially increase OR efficiency.
Implants and instruments of both systems are built upon the 4CIS SOLAR Spine System’s foundation and offer an alternative to traditional pedicle screw fixation. Both the Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.4CIS SARA Spine System and 4CIS VERTU Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following
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/or lordosis);
- Tumor;
- Pseudoarthrosis;
- Failed previous fusion in skeletally mature patients.
- Both the systems were cleared to market by the US FDA under the product code of Thoracolumbosacral Pedicle Screw System (NKB).
SOLCO BIOMEDICAL INDIA and its principal SOLCO BIOMEDICAL KOREA have many years of spinal industry success spanning multiple continents in more than 30 countries. SOLCO and its affiliates are privately held companies with global partners having manufacturing facilities in India and Korea.
For more information on company and products, please contact us on [email protected]
Warm regards,
Solco Biomedical Co. (I) Pvt. Ltd.