Spinal Simplicity Announces FDA 510(k) Clearance of the Minuteman Lateral Percutaneous Interlaminar Fusion Device
OVERLAND PARK, Kan., Jan. 12, 2015 (GLOBE NEWSWIRE) — via PRWEB – Spinal Simplicity, LLC, a spinal device company dedicated to the creation of innovative simple solutions to treat complex spinal disorders, announced today that FDA granted 510(k) marketing clearance for the Minuteman system.
The Minuteman, a pre-packaged sterile supplemental posterior fixation system, offers a minimally invasive alternative to traditional pedicle screws and other spinous process plates that are placed in open procedures for the treatment of degenerative disc disease, spondylolisthesis, tumors and/or trauma. The Minuteman can be placed utilizing two minimally invasive approaches to the spine, posterior unilateral or lateral percutaneous (PercLIF™ – Percutaneous Lateral Interlaminar Fusion).
The PercLIF surgical approach and instrumentation provide a way of quickly and accurately placing the Minuteman between the spinous processes through a one-inch incision. This technique eliminates the lateral dissection of sensitive back muscles often associated with lumbar fusions while maintaining an adequate distance from the neural structures.
“One of the many potential benefits of the Minuteman system is the PercLIF surgical approach to the spine. Direct lateral surgeons will now have the ability to insert a supplemental posterior fixation device with the patient remaining in the lateral decubitous position, typically in about 10 to 15 minutes,” commented Todd Moseley, co-founder of Spinal Simplicity. “As a team, Spinal Simplicity believes this flagship product will provide the foundation for further innovation in the minimally invasive spine market.”
The company anticipates commercial launch of the Minuteman system in the first quarter of 2015.
About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of innovative simple solutions for the treatment of complex spinal disorders. In 2008, the company was founded by Dr. Harold Hess, a practicing neurosurgeon and Todd Moseley, a seasoned entrepreneur with over 20 years of orthopedic and distribution experience. With a focus on quality, the company’s products are designed to further enhance patient care while providing spine surgeons with a greater array of minimally invasive devices. For more information, please visit http://www.spinalsimplicity.com.
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Spinal Simplicity, LLC Carlos Gonzalez +1 913-451-4414 Ext: 309
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