Facet Gun Milestone

A significant milestone in the development of the Facet Fixation System was achieved in April, with the completion of biomechanical testing for the Facet Implant and the filing of the 510(k) for market clearance with the United States Food and Drug Agency (FDA).

Test Results

During the testing, the implants performed very well, and met our expectations for strength and durability, further validating our confidence in the design of the product.

Development efforts on the gun component of the system continue in parallel, as we await a decision from the FDA within the customary 90 - 120 days.

Gearing Up

David Crook and Phil Reed are heading-up the internal effort to convert the existing pre-production prototype guns into the final product that will be available in the fall. Areas of focus include integrating the metal chassis into the plastic housing of the gun, decreasing the weight and bulk, and bolstering the cable track to make it more durable. First-articles of the final version will be assembled in the summer, as we gear-up for mass production for a fall release.

To learn more about the Facet Fixation System, please call 561-36-SPINE.

Copyright © 2006 US Spine