Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Mercy Medical Center Adopts Mako SmartRobotics™ Shoulder: Mercy Medical Center introduced Stryker's Mako SmartRobotics™ shoulder replacement system in Baltimore, applying 3D CT surgical planning and haptic guidance to complex anatomic and reverse arthroplasty.
• ROBUST Trial Validates In-Office Ultrasound Carpal Tunnel Release: Two-year multicenter trial results highlighted in Orthopedics This Week demonstrate that Sonex Health's UltraGuideCTR™ delivers durable symptom relief, zero revisions, and a median return to work in four days.
• SINTX Highlights Silicon Nitride Biomaterial Advantages: Reported by OrthoSpineNews, an orthopaedic masterclass convened by SINTX Technologies, Inc. showcased silicon nitride and SiNERGY™ biocomposites for superior osteointegration and intrinsic bacteriostatic properties over PEEK and titanium.
• DePuy ATTUNE® Revision Knee Cleared: DePuy Orthopaedics, Inc. secured FDA 510(k) clearance (K262130) for the ATTUNE® Revision Knee System to address complex kinematic constraint and bone loss in revision knee arthroplasty.
• S.M.A.I.O KHEIRON® Spinal System Cleared: S.M.A.I.O received FDA 510(k) clearance (K262828) for the KHEIRON® Spinal Fixation System featuring patient-specific K-ROD technology for adult spinal deformity and degenerative thoracolumbar reconstruction.

DAILY ANNOUNCEMENTS BY CATEGORY

Surgical Robotics, AI & Navigation

Mercy Medical Center — Mercy Medical Center Introduces Mako SmartRobotics™ for Total and Reverse Shoulder Arthroplasty

• Summary: Mercy Medical Center in Baltimore has expanded its advanced orthopaedic service line by introducing Stryker's Mako SmartRobotics™ system for shoulder replacement surgery, led by fellowship-trained shoulder specialist Gregory V. Gasbarro, M.D. The robotic-arm assisted platform integrates 3D CT-based patient-specific surgical planning with intraoperative haptic feedback to achieve precise glenoid reaming, version correction, and humeral implant positioning in both anatomic and reverse total shoulder procedures.
• Key Details:
  • Device/System Name: Mako SmartRobotics™ Shoulder System
  • Status: Regional Clinical Adoption & First Mid-Atlantic Cases
  • Clinical Significance: Enhances surgical accuracy in complex glenoid vault preparation and implant orientation, mitigating component malposition and glenoid loosening risks in patients with severe glenohumeral osteoarthritis and rotator cuff tear arthropathy.
• Original Source: OrthoSpineNews

Trauma & Extremities

Sonex Health — ROBUST Trial Validates Long-Term Durability and Rapid Recovery for Office-Based Ultrasound-Guided Carpal Tunnel Release

• Summary: Sonex Health and The Institute of Advanced Ultrasound Guided Procedures announced published two-year outcomes from the ROBUST multicenter prospective trial in Plastic and Reconstructive Surgery – Global Open. Evaluating 149 patients (226 wrists) across seven US centers who underwent office-based ultrasound-guided carpal tunnel release (UGCTR) using the UltraGuideCTR™ device under local anesthesia, the study demonstrated sustained clinical efficacy with median return to normal activities in two days and return to work in four days.
• Key Details:
  • Device/System Name: UltraGuideCTR™ Ultrasound-Guided Carpal Tunnel Release System
  • Status: Peer-Reviewed 2-Year Multicenter Clinical Evidence (PRS Global Open)
  • Clinical Significance: Demonstrates that minimally invasive in-office transection of the transverse carpal ligament under direct ultrasound visualization provides durable symptom resolution through 24 months with a 95.7% patient satisfaction rate and zero surgical revisions, significantly reducing facility costs and convalescence time.
• Original Source: Orthopedics This Week

Spine & Orthobiologics

SINTX Technologies, Inc. — SINTX Launches Silicon Nitride Masterclass Highlighting Antibacterial and Osteointegration Advantages Over PEEK and Titanium

• Summary: SINTX Technologies convened a clinical and biomaterials masterclass with orthopaedic and spine surgery key opinion leaders to evaluate the material advantages of medical-grade silicon nitride (Si3N4) and the SiNERGY™ biocomposite platform. The multidisciplinary panel reviewed retrieval data, surface chemistry, and in vitro models demonstrating that silicon nitride's hydrophilic micro-topography stimulates robust osteoblast differentiation while its surface sub-stoichiometry provides intrinsic resistance to bacterial colonization without requiring antimicrobial coatings.
• Key Details:
  • Device/System Name: Medical-Grade Silicon Nitride (Si3N4) & SiNERGY™ Biocomposites
  • Status: Biomaterials Masterclass & Commercial Platform Expansion
  • Clinical Significance: Presents a compelling biomaterial alternative for spinal interbody cages and arthrodesis implants, addressing the bio-inertness of PEEK and the biofilm vulnerability of metal implants by combining high load-bearing fracture toughness with intrinsic bacteriostatic efficacy and native bone ongrowth.
• Original Source: OrthoSpineNews

RECENTLY INDEXED FDA 510(k) & PMA CLEARANCES — ORTHOPAEDIC

Note: The openFDA database typically indexes clearances 2–4 weeks after the official decision date. Dates shown reflect the FDA decision date, not the indexing date.