Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Smith+Nephew Achieves First Surgical Case with LANDMARK™ Total Knee System: As reported by OrthoSpineNews, Smith+Nephew received FDA 510(k) clearance (K261462) and completed the first surgical case utilizing its LANDMARK™ Total Knee System, featuring 3D-printed CONCELOC™ porous titanium technology and seamless CORI™ handheld robotic integration.
• Xenix Medical Secures FDA Clearance for Riva® Anchor Spinopelvic System: Reported by OrthoSpineNews, Xenix Medical gained 510(k) clearance for its Riva® Anchor Spinopelvic Fixation System with osteogenic NanoACTIV™ surface technology and self-harvesting bone apertures for rigid sacroiliac fusion.
• DePuy Synthes Unveils Next-Gen Trauma Ecosystem at OTA 2026: Featured on OrthoSpineNews, DePuy Synthes highlighted its MOSAIC CT-informed VOLT™ plating platform, Bluetooth®-enabled MAXFRAME AUTOSTRUT™ hexapod system, and previewed VELYS™ Trauma AI trackerless 3D guidance.
• Bone Solutions Mg OSTEOREVIVE™ and Mg OSTEOCRETE™ Cleared: Bone Solutions, Inc. received FDA 510(k) clearance (K262230) for Mg OSTEOREVIVE™ and Mg OSTEOCRETE™ resorbable magnesium bone void fillers.
• Shoulder Innovations N22 Offset Humeral Head Cleared: Shoulder Innovations, Inc. obtained FDA 510(k) clearance (K262173) for the N22 Offset Humeral Head component within its InSet™ total shoulder arthroplasty platform.

DAILY ANNOUNCEMENTS BY CATEGORY

Joint Reconstruction

Smith+Nephew — Smith+Nephew Announces FDA 510(k) Clearance and First Surgical Case of LANDMARK Total Knee System

• Summary: Smith+Nephew announced it has received 510(k) clearance from the U.S. FDA and successfully completed the first surgical case utilizing the LANDMARK™ Total Knee System. Engineered to replicate natural knee kinematics and anatomic motion, the system features a 3D-printed femoral component produced with proprietary CONCELOC™ porous titanium technology and a refined, flat trochlear groove entry designed to optimize patellofemoral tracking.
• Key Details:
  • Device/System Name: LANDMARK™ Total Knee System & CONCELOC™ 3D-Printed Femoral Component
  • Status: FDA 510(k) Cleared (K261462) / Commercial Clinical Initiation
  • Clinical Significance: Replicates physiological knee kinematics while seamlessly integrating with the CORI™ Handheld Robotics platform across hospital and ASC settings to deliver personalized, precision implant positioning without cumbersome robotic footprints.
• Original Source: OrthoSpineNews

Spine & Orthobiologics

Xenix Medical — Xenix Medical Secures FDA Clearance for Riva Anchor Spinopelvic Fixation System with NanoACTIV Surface Technology

• Summary: Xenix Medical announced FDA 510(k) clearance for its Riva® Anchor Spinopelvic Fixation System, developed to facilitate rigid sacroiliac (SI) joint fusion at the caudal base of posterior lumbar and thoracolumbar long constructs. The implant directly connects to the Riva® Posterior Pedicle Fixation System (accepting 5.5mm and 6.0mm rods) and incorporates self-harvesting bone apertures.
• Key Details:
  • Device/System Name: Riva® Anchor Spinopelvic Fixation System
  • Status: FDA 510(k) Cleared
  • Clinical Significance: Enhances biomechanical stability at the lumbosacral-pelvic junction by combining rigid screw-rod integration with osteogenic NanoACTIV™ micro/nanotextured surfaces, driving cellular differentiation and active bony arthrodesis to mitigate pelvic construct failure.
• Original Source: OrthoSpineNews

Trauma & Extremities

DePuy Synthes — DePuy Synthes Unveils Next-Generation Trauma Innovations at OTA 2026 Featuring VOLT Plating, MAXFRAME AUTOSTRUT, and VELYS Trauma AI

• Summary: DePuy Synthes announced a major expansion of its fracture care and deformity correction portfolio ahead of the 2026 Orthopaedic Trauma Association (OTA) Annual Meeting in Nashville. The showcase highlights four new anatomical plating systems within the VOLT™ (Variable Angle Optimized Locking Technology) portfolio designed via MOSAIC machine-learning CT data for shoulder, knee, and ankle fractures, the newly commercialized MAXFRAME AUTOSTRUT™ with Bluetooth® for automated circular hexapod frame adjustments, and previewed VELYS™ Trauma AI-assisted surgery delivering trackerless 3D guidance.
• Key Details:
  • Device/System Name: VOLT™ Plating Platform, MAXFRAME AUTOSTRUT™ with Bluetooth®, & VELYS™ Trauma AI-Assisted Surgery
  • Status: Commercial Portfolio Launch / OTA 2026 Showcase
  • Clinical Significance: Modernizes acute fracture fixation and deformity management by pairing CT-informed anatomic plates with automated remote hexapod monitoring and real-time intraoperative AI fracture reduction assistance.
• 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.