Boston, MA, July 18, 2023 – OrthoSpineNews –
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.
About NanoHive Medical LLC
NanoHive Medical, LLC is a pioneer and leading innovator in 3D printed spinal interbody fusion implants and instrumentation. The company’s proprietary, biomimetic Soft Titanium® technology clearly distinguishes their products in the $1.9B spinal interbody fusion device market. The Hive™ portfolio of interbody fusion devices offers surgeons and patients a set of exceptional characteristics, including optimal biomechanical elastic modulus properties, precise diagnostic imaging capabilities, and ideal osteoblast cell attraction and integration qualities. These features may consistently contribute to strong fusion constructs and positive clinical experiences.
NanoHive Medical is located in Woburn, Massachusetts U.S.A.