Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• MRI2CT Receives FDA 510(k) Clearance for NextMR, Enabling 3D Bone Visualization from Standard Spine MRI: Reported by Orthopedics This Week, MRI2CT Inc. received 510(k) clearance for its NextMR AI platform, which reconstructs submillimeter 3D lumbar spine morphology directly from standard diagnostic MRIs in under 60 seconds to enable zero-radiation surgical planning.
• Smith+Nephew Commercially Launches CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant in Europe Ahead of ICRS Summit: Detailed by Orthopedics This Week, Smith+Nephew launched the aragonite-based CARTIHEAL◊ AGILI-C◊ biphasic scaffold across Europe, providing an off-the-shelf single-stage regenerative solution for simultaneous articular cartilage and subchondral bone restoration.
• Miach Orthopaedics Publishes 2-Year Real-World Bridge Registry Data in KSSTA for BEAR® Implant with 10,000-Patient Milestone: Reported by OrthoSpineNews, two-year post-commercialization Bridge Registry data demonstrated a 5.6% overall retear rate and 87.2% return-to-sport rate for the bio-engineered BEAR® implant, with surgical technique refinements lowering retear rates to 2.5%.
• Rivarp Medical Kentrospine Viktr-MIS® Pedicle Screw System Cleared: Rivarp Medical Pvt., Ltd. secured FDA 510(k) clearance (K252139) for the Kentrospine Viktr-MIS® pedicle screw system, providing minimally invasive posterior thoracolumbar stabilization.
• OrthoPediatrics Pediatric Nailing Platform Femur Cleared: OrthoPediatrics Corp. received FDA 510(k) clearance (K261345) for its specialized pediatric femoral intramedullary nailing platform, designed to optimize fracture fixation while respecting open growth plates.

DAILY ANNOUNCEMENTS BY CATEGORY

Surgical Robotics, AI & Navigation

MRI2CT Inc. — MRI2CT Receives FDA 510(k) Clearance for NextMR, Enabling 3D Bone Visualization from Standard Spine MRI

• Summary: MRI2CT Inc. received FDA 510(k) clearance for NextMR, an AI-powered imaging platform that reconstructs submillimeter 3D bone morphology of the lumbar spine and sacrum directly from standard diagnostic 1.5T and 3T MRI scans in under 60 seconds. The software eliminates the need for secondary preoperative CT scans and patient radiation exposure while providing sagittal, coronal, axial, and 3D volumetric models for robotic and navigation surgical planning.
• Key Details:
  • Device/System Name: NextMR AI Imaging Platform
  • Status: FDA 510(k) Cleared (Software as a Medical Device)
  • Clinical Significance: Enables a zero-radiation, MRI-only preoperative workflow for spine surgeons, delivering CT-equivalent submillimeter cortical bone models from routine diagnostic MRIs without scheduling secondary CT scans or exposing patients to ionizing radiation.
• Original Source: Orthopedics This Week

Joint Reconstruction

Smith+Nephew — Smith+Nephew Commercially Launches CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant in Europe Ahead of ICRS Summit

• Summary: Smith+Nephew announced the commercial launch of its CARTIHEAL◊ AGILI-C◊ cartilage repair implant across Europe, coinciding with the International Cartilage Regeneration & Joint Preservation Society (ICRS) Summit in Porto, Portugal. Constructed from aragonite (a naturally occurring porous calcium carbonate acting as a biphasic scaffold), the implant stimulates simultaneous articular cartilage regeneration and subchondral bone restoration in challenging osteochondral defects.
• Key Details:
  • Device/System Name: CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant
  • Status: European Commercial Launch / CE Marked (Featured at ICRS Summit 2026)
  • Clinical Significance: Five-year multicenter randomized clinical trial results published in AJSM demonstrated superior Knee injury and Osteoarthritis Outcome Scores (KOOS) and significant pain relief out to 60 months compared to surgical standard of care, offering an off-the-shelf single-stage regenerative solution for patients with or without mild-to-moderate osteoarthritis.
• Original Source: Orthopedics This Week

Sports Medicine & Soft Tissue

Miach Orthopaedics — Miach Orthopaedics Publishes 2-Year Real-World Bridge Registry Data in KSSTA for BEAR® Implant with 10,000-Patient Milestone

• Summary: Miach Orthopaedics, Inc. announced two-year outcomes from its post-commercialization Bridge Registry published in Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA), demonstrating a 5.6% overall ACL retear rate and 87.2% return-to-sport rate among patients treated with the Bridge-Enhanced ACL Restoration (BEAR®) implant. Procedure refinements with modified surgical techniques further lowered retear rates to 2.5%, coinciding with over 10,000 U.S. patients treated with the bio-engineered bovine collagen scaffold.
• Key Details:
  • Device/System Name: BEAR® Implant (Bridge-Enhanced ACL Restoration)
  • Status: Post-Market Clinical Registry Publication in KSSTA / Commercial Adoption Milestone (>10,000 Patients Treated)
  • Clinical Significance: Validates real-world clinical safety and durable restorative outcomes for primary ACL healing without autograft harvesting morbidity, showing mean 2-year IKDC scores of 87.4 and KOOS pain scores of 94.7 while highlighting surgeon technique modifications that reduce retear rates down to 2.5%.
• 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.