FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Submissions and Approvals

Solana Surgical’s CrossCHECK Plating System Gets FDA 510(k) Nod

Dec. 23, 2013
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Solana Surgical’s CrossCHECK plating implant system for use in orthopedic and podiatric surgeries of the foot and ankle has won 510(k) clearance from the FDA, the Memphis, Tenn.-based devicemaker says.

The plates used in Solana’s system are manufactured with Type II anodization to increase the device’s strength and make it less vulnerable to fatigue, the company said Friday. Additionally, ridges designed especially for the device enhance its grip and buttress it during the compression process.

The system will be available in the first quarter of 2014 in different sizes to fit specific needs. The first phase of the rollout will include plates for use in fusing the forefoot and midfoot — the most common surgeries performed in patients with arthritis, small joint fractures and bunions. — Lena Freund