Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Globus Medical Secures CE Mark for Excelsius3D™ Intelligent 3-in-1 Imaging Platform: Globus Medical achieved CE mark approval in the EU and UK for Excelsius3D™, combining 3D cone-beam CT, 2D fluoroscopy, and digital radiography with ExcelsiusGPS™ robotic navigation to streamline spinal surgical workflows.
• Ortho Solutions and Cybion Partner to Expand Transverse Tibia Transport (TTT) System in US: Ortho Solutions Inc. partnered with Cybion® GmbH to distribute the original Cybion®-BFIX® TTT distraction-osteogenesis system, providing a microvascular regenerative approach for limb salvage and chronic diabetic ischemic ulcer management.
• Spineart and eCential Robotics Gain FDA 510(k) Clearance for PERLA® TL Navigation on Op.n Platform: Spineart and eCential Robotics secured 510(k) clearance (K261205) for the PERLA® TL navigation application, coupling thoracolumbar instrumentation with robotic guidance.
• Spineart Obtains FDA 510(k) Clearance for BAGUERA® C Cervical Disc Surgical Instruments: Spineart SA cleared dedicated instrumentation (K262639) to optimize implant sizing, trial positioning, and precise keel insertion during cervical disc arthroplasty.
• Corin Secures FDA 510(k) Clearance for Icona Hip Stem in Primary Joint Arthroplasty: Corin, Ltd. obtained 510(k) clearance (K261576) for the cementless Icona Hip Stem, expanding its calcium phosphate-coated femoral portfolio for hip reconstruction.

DAILY ANNOUNCEMENTS BY CATEGORY

Surgical Robotics, AI & Navigation

Globus Medical — Secures CE Mark for Excelsius3D™ Intelligent 3-in-1 Imaging System in EU and UK Markets

• Summary: Globus Medical announced that its Excelsius3D™ intelligent 3-in-1 mobile imaging system has attained CE mark certification for commercial sale across the European Union and the United Kingdom. Designed to interface directly with the ExcelsiusGPS™ robotic navigation platform, Excelsius3D™ combines 3D cone-beam computed tomography (CT), high-resolution 2D fluoroscopy, and digital radiography within a single compact mobile unit. The automated multi-modality system streamlines intraoperative navigation and verification workflows without requiring multiple separate imaging gantries in the surgical suite.
• Key Details:
  • Device/System Name: Excelsius3D™ Intelligent 3-in-1 Imaging System
  • Status: CE Mark Approval / Commercial Availability (EU & UK)
  • Clinical Significance: Eliminates the operational friction of transferring patients between fluoroscopy C-arms and stationary CT scanners during spine and trauma procedures. Synchronized coupling with ExcelsiusGPS™ robotic trajectory navigation reduces total radiation exposure, shortens surgical times, and provides real-time intraoperative 3D confirmation of spinal hardware placement.
• Original Source: Globus Medical Excelsius3D™ CE Mark — OrthoSpineNews

Trauma, Extremities & Limb Reconstruction

Ortho Solutions & Cybion GmbH — Form US Collaboration to Launch the Original Transverse Tibia Transport (TTT) System for Complex Limb Salvage

• Summary: Ortho Solutions Inc. entered into a strategic collaboration with Cybion® GmbH to introduce the clinically proven Cybion®-BFIX® Transverse Tibia Transport (TTT) System across the United States. Developed by Prof. Gang Li, the minimally invasive surgical (MIS) external distraction-histogenesis technology facilitates cortical distraction osteogenesis to stimulate robust peripheral angiogenesis and microvascular regeneration. The protocol is engineered specifically for limb preservation in patients suffering from recalcitrant diabetic ischemic ulcers, neurotrophic wounds, and severe peripheral arterial disease (PAD).
• Key Details:
  • Device/System Name: Cybion®-BFIX® Transverse Tibia Transport (TTT) System
  • Status: US Commercial Collaboration & Clinical Rollout
  • Clinical Significance: Provides an evidence-based, limb-salvage alternative for intractable lower extremity ischemic wounds where conventional endovascular or bypass revascularization has failed or is unfeasible. Inducing localized microvascular neoangiogenesis dramatically accelerates ulcer healing and reduces major below-knee amputation rates in high-risk diabetic cohorts.
• Original Source: Ortho Solutions & Cybion TTT Collaboration — OrthoSpineNews

Spine & Enabling Technologies

Spineart & eCential Robotics — Secure FDA 510(k) Clearance for PERLA® TL Navigation Application on Op.n Robotic Platform

• Summary: Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA® TL navigation application for seamless integration with the Op.n Navigation and Robotic-Assisted Platform. The milestone couples Spineart’s PERLA® thoracolumbar pedicle screw system with eCential’s open-architecture stereotaxic robotic guidance, providing unified planning, intraoperative tracking, and robotic instrument alignment for both open and minimally invasive spine procedures.
• Key Details:
  • Device/System Name: PERLA® TL Navigation Application (Op.n Navigation and Robotic-Assisted Platform)
  • Status: FDA 510(k) Cleared (K261205)
  • Clinical Significance: Consolidates preoperative CT planning, robotic arm trajectory execution, and pedicle screw instrumentation into a cohesive, intraoperatively verified surgical workflow. Enhances breach avoidance and precision in complex deformity or minimally invasive thoracolumbar instrumentation while reducing cumulative fluoroscopic exposure for the surgical team.
• Original Source: FDA 510(k) Spine Recap — BONEZONE

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