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The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into 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 spinal fractures and/or traumatic dislocations: instability of deformity: failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and 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 Tiger Occipital-Cervical-Thoracic Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance 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 Tiger Occipital-Cervical-Thoracic Spinal Fixation System may be connected to the components in the Tiger Spine System using the side by side and end to end rod to rod connectors.

The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is an implant system used to provide temporary immobilization and stabilization of the cervical spine and occipito-cervicothoracic junction while fusion occurs. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System consists of screws, rods, hooks, plates, and connectors in various configurations which can be assembled to create a construct that meets the need of the patient. It can be used for single or multiple level fixation. Spinal rods and hooks may be contoured intraoperatively to meet specific anatomical requirements.

Implants in the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.

This document is a 510(k) summary for the CoreLink Tiger® Occipital-Cervical-Thoracic Spinal Fixation System, which is a medical device. This type of document is filed with the FDA to demonstrate that a new device is substantially equivalent to a predicate device already on the market, meaning it does not raise new questions of safety or effectiveness.

Therefore, the input requests about acceptance criteria and study details (like sample size, ground truth, expert qualifications, and MRMC studies) are not applicable to this document. This filing is not a study proving device performance against acceptance criteria. Instead, it's a regulatory submission asserting similarity to an already approved device.

Specifically:

• Acceptance Criteria and Reported Device Performance: This document doesn't provide acceptance criteria or a performance study. It states that mechanical testing was not required because the worst-case components were previously tested under a prior clearance (K132504).
• Sample Size and Data Provenance: No new testing was conducted for this specific submission, so there is no new sample size or data provenance to report. The submission refers to prior testing for a predicate device.
• Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, and Ground Truth for Training Set: These are concepts related to clinical or performance studies, which were not conducted for this particular 510(k) submission as it relies on substantial equivalence to a predicate device.

The main conclusion of the document is that the "subject modified Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is identical to previously cleared Tiger® Occipital-Cervical-Thoracic Spinal Fixation System" and has "similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices." It explicitly states that "The modifications do not raise any different questions of safety and effectiveness."

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