Silverstone Titanium FDA 510(k) Clearance
West Chester PA, March 17, 2017 – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces the FDA clearance of the Silverstone Titanium Interbody Fusion (IBF) System. The Silverstone Titanium IBF System is designed to be implanted in the lumbar spine to aid in the stability and support of vertebral bodies during fusion.
The Silverstone Titanium IBF System is a simple, yet comprehensive, system that includes both PLIF and TLIF implants, and supporting instrumentation. Introducing Altus Spine’s MicroLOC™ technology, the Silverstone Titanium IBF System incorporates the latest combination of macro- and micro-endplate surface texture design. MicroLOC™ surface technology results in a proprietary, porous grip surface intended to provide an optimal environment for initial bone growth while minimizing the potential for implant migration.
“The development of MicroLOC™ surface technology was in response to surgeon requests for implant surfaces that encourage better on-growth of bone,” says Michael Fitzgerald, CEO and President of Altus Spine. “The Silverstone Titanium implant is the first implant to employ MicroLOC™ surface technology. The combination of easy implant insertion with the MicroLOC™ porous surface results in a state-of-the-art IBF implant.”
The Silverstone Titanium IBF System was created through the concentrated efforts of surgeons, engineers, and machinists to deliver the most advanced and cost effective implant system possible. Its release closely follows last month’s market release of the Fuji Cervical Plate System.
The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.
Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices. Altus strives to improve patient care by designing and developing products to meet the highest standards in an ever changing and evolving field. Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world. For additional information, and to inquire about distribution opportunities , please visit www.altus-spine.com
Forward Looking Statements
All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions. These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected. These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases. All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA). Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements. Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.