NanoHive Receives FDA 510(k) Clearance for Hive™ Standalone Cervical

Jan 9, 2023

Hive Stand Alone Cervical

NanoHive Medical has received 510(k) Clearance from the U.S Food and Drug Administration (FDA) for its Hive™ Standalone Cervical System. The implant system features both a zero profile design, interfixated with two self-tapping screws, as well as a cage and plate fixation option.

Both interbody cage options are available in multiple footprints, heights and lordoses to accommodate patient anatomy and feature the innovative Hive™ Soft Titanium® technology.

Patrick O’Donnell, President & CEO of NanoHive Medical remarks that “This FDA Clearance represents a very exciting and momentous achievement for the company. With the Q1, 2023 launch of the Hive™ Standalone Cervical System, combined with our Hive™ Standalone Anterior Lumbar System, the company is positioned as the leader of 3D printed titanium anterior stand-alone fusion systems. Additionally, the new cervical system is ideally designed to address the rapid migration of cervical fusion procedures to ambulatory care surgery center facilities.

Hive Stand Alone Cervical

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 provide surgeons and their patients ideal biomechanical elastic modulus properties, clear and precise diagnostic imaging capability, osteoblast cell attraction and integration – all features that lead to consistently strong fusion constructs and efficacious clinical experiences.

NanoHive Medical is located in Woburn, Massachusetts U.S.A.

Contact: Patrick O’Donnell, CEO & President at