West Chester, PA – Tuesday, June 21st, 2022 /OrthoSpineNews/ – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces FDA 510(K) clearance of Sochi OCT System.
The Altus Spine Sochi OCT System provides a seamless transition from occiput to sacrum. The Sochi OCT System is comprised of polyaxial screws, hooks, rods, locking screw assemblies and connectors which may be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.
“To adapt to a wide variety of patient anatomies, while also accommodating surgeon preference, our team designed a system that can be configured in multiple different variations.” said Michael Fitzgerald, President and CEO.
The FDA’s action means that The Sochi OCT Spinal System is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput – T3). The intended indications are as follows: Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Deformities or Curvature, Tumors, Pseudarthrosis, Atlanto/axial fracture with instability, Occipitocervical dislocation, and Revision of previous cervical and upper thoracic spine surgery. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Altus Spine Sochi OCT Spinal System can also be linked to the Monaco Pedicle Screw System with the use of transition rods and rod connectors.
“This FDA clearance is a great addition to our diverse portfolio of products. Its ability to configure and adjust to a wide variety of patients is a design aspect that is very beneficial in the field,” said Fitzgerald, “As we continue advancing our portfolio by creating innovative products and technologies, our leading goal is providing better outcomes for our patients while solving complications surgeons face in the OR.”
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Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices. Altus strives to improve patient care by designing and manufacturing products to meet the highest standards in an ever changing and evolving field. Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world. For additional information, or to inquire about distribution opportunities, please contact us at email@example.com.
Forward Looking Statements
All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions. These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected. These uncertain factors include, but are not limited to: acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases. All risks and potential complications can be found in our most recent 510(k) report from the Food and Drug Administration (FDA). Given the constantly changing market, readers are encouraged to not place undue reliance on forward-looking statements. Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.