Spine, orthopedic tech earning FDA nods in November

News & Analysis

The FDA issued several spine and orthopedic devices and technologies in November.

1. Augmedics earned FDA 510(k) clearance for its CT-to-fluoroscopy registration method. It allows surgeons to navigate cases with preoperative CT scan and fluoroscopic images. The images are from a standard 2D C-arm, and the technology eliminates the need for 3D intraoperative imaging.

2. Remedy Logic, a radiology AI company, received FDA clearance for RAI, an AI-powered program for spine MRI interpretation. 

3. Acuitive Technologies earned FDA clearance for the Citrepore bioactive bone filler.

4. Foundation Surgical earned FDA 510(k) clearance for its Vertiwedge intraosseous device. Vertiwedge is a motion-sparing partial vertebral body replacement device that pairs with the newly launched Vertebral Body Osteotomy procedure.

5. Exactech received 510(k) clearance for its Truliant Porous Tibial Tray, a 3D tibial knee implant.

6. Orthopedic surgical robot developer Think Surgical has earned clearance from the FDA to use its Tmini miniature robotic system alongside the LinkSymphoKnee from German-based Waldemar Link GmbH & Co. under a collaboration agreement between the two companies. 

7. Think Surgical also earned FDA clearance to use its Tmini miniature robotic system alongside the Maxx Orthopedics' knee implants and for use with b-One's Mobio total knee system.

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