July 13, 2014 11:19 PM ET

Healthcare Equipment and Supplies

Company Overview of X-spine Systems, Inc.

Company Overview

X-spine Systems, Inc. manufactures spinal implants and instruments for spinal surgery. The company provides thoracolumbar products, including Axle Interspinous Fusion System, an internal fixation device; Butrex Anterior Lumbar Buttress Plating System, which provides two-point fixation and integrated locking mechanism; FixcetSpinal Facet Screw System, a percutaneous facet screw system with dual-compression thread and single thread screws; and FortexPedicle Screw System that creates a pedicle screw system. It also offers X90Pedicle Screw System that combines rotary locking technology and biomechanical performance and allows rod locking; XPORT Fortex Muscle Sparing Approach, a tissue-sparing in...

452 Alexandersville Road

Miamisburg, OH 45342

United States

Founded in 2003

Phone:

937-847-8400

Fax:

937-847-8410

Key Executives for X-spine Systems, Inc.

Chief Executive Officer
Chief Financial Officer
Vice President
Director of Engineering
Compensation as of Fiscal Year 2014.

X-spine Systems, Inc. Key Developments

X-spine Announces Market Launch of Three Spinal Implant Systems

X-spine announced the market launch of three recently USFDA-cleared spinal implant systems. The systems are the IRIX-C(TM) cervical integrated interbody fusion system, the AXLE-X(TM) extended angle interspinous fixation system and the SILEX(TM) sacroiliac joint fusion system. IRIX-C(TM) represents the latest generation of X-spine cervical fixation technology. With benefits to both patient and surgeon, the implanted device lies completely within the disk space, with zero-impingement on adjacent structures. Incorporating biomaterials and manufacturing processes, the device combines a polymer body, titanium plasma coating of bone-apposing surfaces, and integrated variable-angle screw fixation. Additionally, IRIX-C(TM) represents the first in a forthcoming family of IRIX(TM) integrated interbody devices currently being developed by X-spine. AXLE-X(TM) represents the newest evolution of X-spine's established line of AXLE(TM) interspinous fixation and fusion devices. Utilizing a bevel-angle plate design and novel unidirectional tooth pattern, AXLE-X(TM) demonstrates superior pull-off resistance to alternative designs in laboratory studies simulating fixation at the laminar-spinous junction. SILEX(TM) is X-spine's novel sacroiliac fusion device. By utilizing a combination of unidirectional compression threading, titanium coating, and internal fusion chamber, SILEX(TM) provides excellent biomechanics for sacroiliac fusion procedures.

X-spine Systems, Inc. Announces FDA Clearance of New Spinal Implant System

X-spine Systems, Inc. announced a new USFDA clearance for the Zygafix(TM) Facet Fusion System. The newly-cleared Zygafix(TM) system allows for fusion and stabilization of the facet joint (also termed the zygapophyseal joint) in eligible patients whom appropriate non-surgical treatment has failed. The device can be placed through a minimally-invasive approach, and incorporates a hollow fenestrated titanium compression screw with internal bone graft in order to achieve a solid fusion. Unlike intra-facet systems which simply consist of a solid bone implant wedged into the facet joint which do not provide mechanical fixation, the Zygafix(TM) is a true fixation system incorporating a titanium compression screw. The implant is packed with bone graft and creates a fusion mass across the facet joint and imparts long-term stability. The implant and instrumentation suite allows for either open or minimally-invasive exposure. Additionally, the implant can be placed through a simple trans-facet approach in addition to typical facet approaches.

X-spine Systems, Inc. Announces FDA Clearance of New Implant System

X-spine Systems, Inc. announced a new USFDA clearance for the Silex sacroiliac joint fusion system. The newly-cleared Silex system allows for fusion and stabilization of the SI joint in eligible patients whom appropriate non-surgical treatment has failed. The device can be placed through a small incision, and incorporates a proprietary dual-pitch compression-thread design and titanium plasma coating to stabilize the SI joint in fusion procedures. The design of the implant allows for bone graft to be introduced into the joint and implant in order to achieve a solid fusion. Unlike some recently-introduced SI arthroplasty-type systems which are not compatible with direct bone grafting of the SI joint space, the Silex is a true bony fusion and arthrodesis system. The implant and instrumentation suite allows for direct exposure and preparation of the SI joint surface, placement of bone graft into the SI joint space under direct visualization, and placement of bone graft directly within the Silex implant itself.

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