NanoHive Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 22mm length Hive™ PL Interbody System. The 22mm length implants are a line extension to the current Hive PLIF interbody devices and feature a 9mm width and variety of height and lordotic options to accommodate patient anatomy.
Additionally, the regulatory clearance includes updated description of the microscopic roughened surfaces with micro and nano-scale features found on all surfaces of the Hive Soft Titanium® interbodies, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.
The company’s Hive Lumbar Interbody System, with a microscopic roughened surface and micro and nano-scale features, is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. The system must be used with supplemental fixation, with autograft or allograft bone.