Solana's CrossCHECK Plating System receives FDA clearance

Dec 20 2013

Solana Surgical, LLC (Solana), a growth extremity company, announces the FDA Clearance of the CrossCHECK™ Plating System, a new implant system for orthopedic and podiatric surgeons' use in foot and ankle procedures. Commercialization will follow in the first quarter of 2014.

The first phase of commercialization will include plates that will be primarily used for stabilization and fixation (leading to fusion) in the forefoot and mid-foot. 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.

Unlike other plating systems on the market, the CrossCHECK™ System offers unique compression and stabilization features: the plates are manufactured with a Type II anodization, which enhances the fatigue strength of the device, and thus improves stabilization. In addition, specially designed ridges are built into the plates to enhance grip, and act as a buttress during the compression process. "Studies have shown that similar ridges can also improve host bone health," explains Rebecca Wahl, Vice President of Research and Development.

The CrossCHECK Plating System offers various sizes and configurations for specific surgical needs.

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