FDA Clears Anterior Cervical Plate System from Spinal USA

FDA Clears Anterior Cervical Plate System from Spinal USA

PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announces that its wholly owned subsidiary, Spinal USA, Inc., received 510(k) clearance from the FDA on July 11, 2012 for the Slimplicity Solo Anterior Cervical Plate System. Slimplicity Solo adds another important cervical product to the broad and expanding Spinal USA product portfolio.

“The hours we’ve devoted to product research and development is producing great results”

“The hours we’ve devoted to product research and development is producing great results,” stated Rich Dickerson, President of Precision Spine. “With Slimplicity Solo, we have our third product launch in two years. This product will provide surgeons with an exciting new fixation system for the cervical spine, offering potential benefits over existing, traditional cervical plating systems. We also believe this product will have application in the expanding same day surgery market segment.”

Since 2011, Spinal USA introduced two other products, the Vault™ ALIF System and the Sure Lok™ Mini Posterior Cervical/Upper Thoracic System in April and September of 2011, respectively.

This new anterior cervical plate system offers one of the slimmest profile plates available in the market and is designed to have a simple and secure locking mechanism that accommodates visual locking confirmation. The system is comprised of one and two level plates and 4.5mm fixed and variable screws, and provides an ergonomic color coded instrument set.

After evaluating the new system, Dr. Henry E. Aryan, a board certified neurosurgeon and Associate Professor at the University of California, San Francisco (“UCSF”), commented, “The Slimplicity Solo is well designed for use in 1- and 2-level ACDFs. Its narrow footprint and low profile are dimensioned to reduce strap muscle dissection and dysphagia. Its single, larger diameter screw-plate construct enables stability and facilitates quicker implantation. The system design lends itself for use in women, in thinner patients, or adjacent to an existing construct.”

The Slimplicity Solo system is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

About Precision Spine and Spinal USA

Precision Spine, Inc., the parent company of Spinal USA, Inc., is a privately held company headquartered in Parsippany, New Jersey, with manufacturing facilities in Mississippi. Precision Spine is dedicated to providing innovative, quality spine products that are designed to help treat serious orthopedic medical conditions in a cost effective manner. For more information, visit www.precisionspineinc.com.

Spinal USA (Pearl, MS) has announced that its Slimplicity Solo anterior cervical plate system has been cleared via FDA’s 510(k) pathway, making it the third product that the company has introduced in the last two years. In 2011, the company debuted the Vault ALIF System and the Sure Lok Mini Posterior Cervical/Upper Thoracic System.

The Simplicity Solo device was designed for fixation of the C2–C7 vertebrae to manage trauma, degenerative disc disease, deformity, pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The manufacturer describes the titanium device, which comes with 4.5-mm fixed and variable screws, as “one of the slimmest profile plates available in the market.”

From the press release:

After evaluating the new system, Dr. Henry E. Aryan, a board certified neurosurgeon and Associate Professor at the University of California, San Francisco (“UCSF”), commented, “The Slimplicity Solo is well designed for use in 1- and 2-level ACDFs. Its narrow footprint and low profile are dimensioned to reduce strap muscle dissection and dysphagia. Its single, larger diameter screw-plate construct enables stability and facilitates quicker implantation. The system design lends itself for use in women, in thinner patients, or adjacent to an existing construct.”

source : http://www.businesswire.com/news/home/20120910006573/en/Precision-Spine-Announces-FDA-Approval-Slimplicity%C2%AE-Solo

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