Industry News

Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• FDA Grants 510(k) Clearance for BoneEnhance Machine Learning Layer on RIVANNA Accuro XV Platform: Reported by OrthoSpineNews, RIVANNA received FDA 510(k) clearance for BoneEnhance, an ultrasound machine learning software module automating three-dimensional bone segmentation and real-time color-coded visualization for musculoskeletal trauma triage.
• Forma Medical Receives U.S. Patent Covering Minimally Invasive Plate Arthrodesis (MIPA) Methods Across the Foot: Reported by OrthoSpineNews, Forma Medical Inc. was issued U.S. Patent No. 12,751,749 for Minimally Invasive Plate Arthrodesis (MIPA) surgical methods across midfoot and hindfoot joints, building on clinical use in over 1,000 procedures to deliver rigid plate stability while preserving soft-tissue envelopes.
• International Scapholunate Ligament Registry Analyzes 15-Center Longitudinal Trajectories and Radiographic Outcomes: Reported by Healio Orthopedics, investigators from Hospital for Special Surgery presented prospective registry outcomes across 15 centers and 70 patients at the ASSH Annual Meeting (Paper 1362), benchmarking recovery trajectories at 6-week and 12-month intervals and identifying dorsal scaphoid translation as a primary radiographic correlate of success.
• Microport Orthopedics Obtains 510(k) Clearance for NEXUS® Hip Stem: Microport Orthopedics, Inc. received FDA 510(k) clearance (K262473) for its NEXUS® Hip Stem, indicated for cemented or uncemented total hip arthroplasty.
• ZSFab Receives 510(k) Clearance for ZSAlign Cervical Interbody System: ZSFab, Inc. secured FDA 510(k) clearance (K263113) for the ZSAlign Cervical Interbody System with integrated fixation for cervical spine fusion.

DAILY ANNOUNCEMENTS BY CATEGORY

Surgical Robotics, AI & Navigation

RIVANNA: FDA Grants 510(k) Clearance for BoneEnhance Machine Learning Layer on RIVANNA Accuro XV Platform

• Summary: RIVANNA announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for BoneEnhance, a machine learning software module for the Accuro XV diagnostic ultrasound system. The module segments bone and surrounding tissues and supports visualization of skeletal anatomy in three dimensions during image review. Accuro XV was cleared in April 2026 for B-mode imaging in musculoskeletal conventional and superficial applications, utilizing a conformable three-dimensional probe that automates large field-of-view image acquisition. BoneEnhance identifies bone and surrounding tissues within each volumetric acquisition and highlights them with color-coded overlays on the two-dimensional B-mode image. In an independent test set of 233 volumetric datasets comprising 69,900 images from 173 subjects evaluated by three board-certified radiologists, per-volume label prediction accuracy ranged from 95.1% to 100.0%.
• Key Details:
  • Device/System Name: Accuro XV Diagnostic Ultrasound System and BoneEnhance Machine Learning Software Module
  • Status: FDA 510(k) Cleared (Machine Learning Software Module)
  • Clinical Significance: Automates three-dimensional volumetric bone segmentation and real-time color-coded anatomical visualization for musculoskeletal trauma triage and point-of-care extremity imaging, reducing diagnostic delays and unnecessary emergency X-ray referrals.
• Original Source: OrthoSpineNews

Trauma & Extremities

Forma Medical Inc.: Forma Medical Receives U.S. Patent Covering Minimally Invasive Plate Arthrodesis (MIPA) Methods Across the Foot

• Summary: Forma Medical Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 12,751,749, titled 'System for Joint Fixation of Extremity Bone and Related Methods,' on October 6, 2026. The patent covers surgical methods for Minimally Invasive Plate Arthrodesis (MIPA), in which a plate is introduced and secured across a joint of the foot through small incisions rather than traditional open exposures. Adapting principles from minimally invasive plate osteosynthesis (MIPO) in trauma care to elective joint fusion, MIPA delivers rigid plate stability through reduced incisions. The methods build upon Forma Medical's flagship OptimalMTP system for first MTP joint arthrodesis, which received FDA 510(k) clearance in 2024 and has been utilized in over 1,000 clinical procedures, with patent claims extending across midfoot and hindfoot joints.
• Key Details:
  • Device/System Name: Minimally Invasive Plate Arthrodesis (MIPA) Surgical Methods and OptimalMTP System
  • Status: U.S. Patent Issued (U.S. Patent No. 12,751,749)
  • Clinical Significance: Eliminates the historical trade-off between open rigid plate fixation and percutaneous screw-only constructs, preserving soft-tissue envelopes and periosteal blood supply across elective foot and ankle fusions.
• Original Source: OrthoSpineNews

Clinical & Registry Evidence

Hospital for Special Surgery: International Scapholunate Ligament Registry Analyzes 15-Center Longitudinal Trajectories and Radiographic Outcomes

• Summary: Investigators led by Dr. Troy B. Amen and Dr. Scott W. Wolfe from Hospital for Special Surgery, collaborating across 15 national and international centers, presented prospective multi-center outcomes from an international scapholunate ligament registry comprising 70 patients at the American Society for Surgery of the Hand (ASSH) Annual Meeting (Paper 1362). The study prospectively tracked patients undergoing scapholunate ligament repair or reconstruction at 6-week, 3-month, 6-month, 9-month, and 12-month intervals. Patients experienced transient worsening of pain, wrist motion, and pinch strength at 6 weeks upon cast removal, followed by marked improvement at 3 months and significant recovery at 12 months. Radiographic subanalysis demonstrated that dorsal scaphoid translation and the radioscaphoid angle correlated strongly with clinical success, challenging the traditional reliance on scapholunate gap as the primary radiographic endpoint.
• Key Details:
  • Device/System Name: International Scapholunate Ligament Registry (15-Center Prospective Clinical Database)
  • Status: Multi-Center Prospective Registry Outcomes Presented (ASSH Annual Meeting Paper 1362)
  • Clinical Significance: Establishes the first standardized international benchmark for postoperative recovery trajectories following scapholunate surgery, guiding patient expectations regarding transient early postoperative stiffness and shifting radiographic endpoints toward dorsal scaphoid translation and radioscaphoid angle.
• Original Source: Healio Orthopedics

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

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