Healthcare Industry News:  Fixation System 

Devices Orthopaedic FDA Product Launch

 News Release - September 24, 2013

Solana Surgical Receives FDA Clearance, Launches the FuseFORCE(TM) SuperElastic Fixation System

First Sterile, Fully Contained, Single Pack/Single-Use Kit with Implant and Instruments

MEMPHIS, Tenn.--(Healthcare Sales & Marketing Network)--Solana Surgical, LLC (Solana), a growth extremity company, announces the launch of the FuseFORCE™ SuperElastic Fixation System, a new implant system for orthopedic and podiatric surgeons’ use in fusing the small joints in the foot and ankle, and hand and wrist. Commercialization follows a successful FDA 510K clearance in mid-July.

The FuseFORCE System consists of a complete, sterile kit containing super-elastic Nitinol (memory metal) staples, and all of the instruments required for implantation. A specially-designed inserter allows the implant to be loaded without handling by the surgeon.

Unlike other Nitinol implants on the market, the FuseFORCE implant requires no heat to activate its compressive properties. “The super-elastic properties of the FuseFORCE Implant allow the implant legs to act as springs, rather than relying on heat for activation. This built-in spring effect creates the compression and fixation needed for many procedures in the foot and hand,” explains Rebecca Wahl, Vice President of Research and Development.

Fusion is often the preferred procedure to relieve pain and correct skeletal alignment issues in patients with arthritis, as well as small joint fractures and bunions. The FuseFORCE System is available in various sizes for specific surgical needs.

Pre-Sterilization Saves Hospital Costs

A sterile, single use system, the FuseFORCE kit is one of many existing and future products developed by Solana that do not require hospital sterilization.

“Hospitals and surgery centers are beginning to request pre-sterilized implants and instruments as a way to reduce their own sterile processing and liability costs. Solana is a leader in the extremity market for this innovation,” says Alan Taylor, President and CEO.

The FuseFORCE System joins a growing family of Solana Surgical products that include the TenFUSE™ PIP, TenFUSE™ Nail, SolaFIX™ Screw System, MDI Metatarsal Decompression Implant, TenSIX™ Acellular Dermal Tissue, TenSIX™ Cancellous Sponge, TenSIX™ Moldable Putty and the GaitWAY™ Implant System.

For more information, contact Solana Surgical at 855.214.1860; via email at info@solanasurgical.com; or on the web at www.SolanaSurgical.com.

About Solana Surgical

Solana Surgical, LLC is a global extremity orthopedic company that develops breakthrough solutions to restore motion while relieving pain for patients, and that improve surgical outcomes for surgeons. Having launched its first product in 2011, Solana Surgical’s goal is to advance the science in the foot, ankle and hand markets by meeting unmet needs with innovative new products. For more information, please visit www.SolanaSurgical.com.

Safe-Harbor Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms. The Company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting Solana Surgical LLC’s business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.


Source: Solana Surgical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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