Recent FDA 510(k) Clearances in Spine
These clearances span implants and robotic/digital products with application in the spinal segment, from companies both familiar and new....
Sep 15 2022,
Competitive Landscape
Stryker Launches New Gamma4 Hip Fracture Nail
Stryker's Gamma System will provide surgeons with the next generation of Stryker’s intramedullary nailing system....
Sep 06 2022,
Zimmer Biomet Partners to Market HipInsight Mixed Reality System
Surgical Planning Associates will exclusively co-market the HipInsight mixed reality system for total hip replacement....
Sep 06 2022,
eCential Robotics Gains 510(k) for Surgical Robotic Platform
This clearance addresses the use of intra-operative 2D and 3D imaging, navigation and robotic guidance in spine surgery....
Sep 06 2022,
First Clinical Use of Medartis LapiPrep System
The new Lapidus system allows the surgeon to correct and continuously adjust all planes of deformit throughout the procedure....
Sep 06 2022,
Point Robotics Receives 510(k) for POINT Kinguide Robotic-Assisted Surgery
This is reportedly the world's first hand-held robot framework equipped with a parallel manipulator for orthopedic applications....
Sep 06 2022,
FDA Cybersecurity Update Takes Aim at Medical Device Quality Systems
FDA is recommending comprehensive cybersecurity risk management programs and documentation consistent with device quality systems....
Sep 06 2022,
Exactech Launches Novel Total Hip Replacement System
The Spartan Stem and Logical Cup system for total hip arthroplasty is suitable for use in ambulatory surgical centers....
Aug 23 2022,
Moximed Raises $40 Million to Support the MISHA Knee System
MISHA is described as the world’s first implantable shock absorber for the knee, and is based on the benefits of...
Aug 23 2022,
FDA 510(k) Clearance for MicroPort Navibot SkyWalker Robotic System
SkyWalker will initially offer a robotically assisted total knee replacement solution compatible with the Evolution Medial-Pivot Total Knee....
Aug 23 2022,
3D-Side Gains 510(k) for Ankle Replacement Pre-Op Planning
The web-based platform allows for review of a 3D pre-operative planning of the reconstruction of the ankle pathology....
Aug 23 2022,
EPA Provides EtO Update by Calling Out Sterilization Plants, Nodding to Future Pollution Rule
The agency said that its new analysis findings would inform a long-awaited air pollution rule that could have consequences for...
Aug 08 2022,
CONMED to Acquire Biorez and its BioBrace Implant Technology
Through this acquisition, CONMED gains next-generation bioinductive collagen scaffold technology for application in sports medicine soft tissue healing....
Aug 03 2022,
Zimmer Biomet/HSS to Partner on AI in Robotic Joint Replacement
The collaboration will co-develop artificial intelligence-based decision support tools for robotic-assisted joint surgery....
Aug 03 2022,
THINK Surgical and Curexo Partner on Development and Distribution in Robotics
THINK and Curexo have a strong working relationship, and Curexo distributes THINK's TSolution One platform in Korea and Vietnam....
Aug 03 2022,