LinkSPINE Announces FDA (510)k Clearance of FacetLINK Fixation Platform

March 4, 2015

Rockaway, NJ – LinkSPINE, a company focused upon simple, less invasive implants and techniques for spinal surgery is pleased to announce FDA (510)k Clearance of FacetLINK. FacetLINK uses two screws and a novel plated cross-connector assembly to stabilize the spine following a tissue-sparing midline or microsurgical decompression. The plate assemblies are available in numerous sizes as well as an expandable version to accommodate various anatomical and pathological scenarios, as well as surgeon preferences. 

Christopher Chaput, MD, an Orthopaedic Spine Surgeon and Director of Orthopaedic Research at Baylor Scott and White in Temple, TX states, “FacetLINK provides me with an additional tool for treating cases with mild to moderate instability, where a less extensive exposure is desired. The ability to achieve bilateral fixation in these cases through the unilateral exposure I work through for my micro-decompression is an attractive feature to me.” 

Faheem Sandhu, MD, Professor of Neurosurgery and Director of Spine Surgery at Medstar Georgetown Hospital in Washington, DC comments, "the FacetLINK platform offers the option to use a small implant that secures rigid biomechanical stability, but without the additional tissue exposure required to seat conventional pedicle screw and rod fixation. This is an attractive alternative for cases with mild to moderate instability." 

Helmut D Link, Chairman of LinkSPINE offers, “With our FacetLINK stabilization devices we added a set of less invasive spinal implants to the spine surgeon’s armamentarium, that are designed to incorporate important biomechanical lessons learned over decades of involvement in other areas of bone and joint replacement. We are excited to bring the FacetLINK platform to the US market, and look forward to building on our experience in reconstructive orthopaedics and spinal prostheses.” 

Massimo Calafiore, President of LinkSPINE adds, “FacetLINK fulfills a desire for a simple, less invasive approach to lumbar spine surgery, adding true value for surgeons who are tiring of long learning curves.” 

Dennis Farrell, Vice-President of Marketing and Product Development agrees, “Throughout the course of the last several years, we have heard several consistent themes from spine surgeons around the world, including a desire for simple, elegant, and less invasive techniques that allow them to accomplish their surgical objectives, and the need to focus tightly on patient outcomes. We look forward to working towards these goals as we begin our clinical experience with FacetLINK in the US.” 

The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from L3 to S1 (inclusive). The Platform is indicated for the treatment of any or all of the following: 

1.     Spondylolisthesis. 

2.     Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies. 

3.     Degeneration of the facets with instability. 

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