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The Altus Spine Sochi OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: Traumatic spine fractures and/or traumatic dislocations; Instability or deformity; Failed previous fusions (e.g. pseudarthrosis); Tumors involving the cervical spine; Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Altus Spine Sochi OCT System is also intended to restore the integrity of the spinal column even in the absent of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Altus Spine Sochi OCT System may be used with the Theken Coral Spinal System with the use of transition rods and rod connectors.

The Altus Spine Sochi OCT Spinal System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Sochi OCT Spinal System attaches to the vertebral body by means of screws to the cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the "Altus Spine Sochi OCT Spinal System." This document is an FDA clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data for the device itself.

Based on the provided text, the device is deemed substantially equivalent, and the clearance is based on the absence of testing required because the device is identical in design, dimensions, and instrumentation to the predicate device. Therefore, no studies were conducted to prove the device meets acceptance criteria, as the acceptance criteria are met by virtue of being identical to a previously cleared device.

Specifically, the document states:

• "No testing is required. The Altus Spine Sochi OCT Spinal System are manufactured the same as the primary predicate Theken Atoll OCT Spinal System (K083863)."
• "The Altus Spine Sochi OCT Spinal System is the same as the primary predicate in regards to implant materials and surgical technique. The only difference between the primary predicate and the Altus Spine Sochi OCT Spinal System is the name. There were no design changes to the primary predicate when compared to the Altus Spine Sochi OCT Spinal System."

Therefore, I cannot extract the information requested regarding acceptance criteria and performance study details because the submission is based on substantial equivalence to an existing device, not on new performance testing. The "proof" is that it is the same as an already cleared device.

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