HD LifeSciences has received FDA 510(k) clearance for its Hive-C IBFD, a system of interbody devices for anterior cervical fusion procedures.
The Hive-C implant system will be commercially available in July 2018.
The devices are based on the company’s patented, additive-manufactured Soft Titanium technology, designed to provide optimum stiffness, ideal imaging and a bioactive surface treatment, a press release states.
Hive-C implants are offered in a range of sizes and geometries.
Ian Helmar, chief product officer, says of the news: “We are excited to serve the high demand for the benefits of Soft Titanium technology in the cervical market. We look forward to expanding our product offering with additional regulatory clearances by the end of the year”.
This FDA clearance follows the approval in 2017 of HD Lifesciences’ NanoHive lumbar interbodies, which also featured the company’s proprietary Soft Titanium technology platform.