Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Medtronic INFUSE® Bone Graft for TLIF Receives CMS New Technology Add-on Payment (NTAP) Eligibility: Medtronic announced that CMS granted NTAP eligibility for INFUSE® Bone Graft in transforaminal lumbar interbody fusion (TLIF) procedures effective October 1, 2026, lowering hospital adoption barriers for recombinant bone morphogenetic protein in inpatient spine surgery.
• Stryker Debuts FDA-Authorized SportSuite Vision for Apple Vision Pro with Landmark Hip Arthroscopy Case: Stryker completed the first surgical procedure utilizing its FDA De Novo-authorized SportSuite Vision application on Apple Vision Pro at Duke Health, integrating live arthroscopic feeds, preoperative CT reconstructions, HipCheck, and HipMap data into an ergonomic spatial computing environment within the sterile field.
• ONWARD Medical Achieves First Implant in Landmark EIGER Feasibility Study for Spinal Cord Injury Mobility: ONWARD Medical announced the first human implant in its EIGER clinical feasibility study evaluating the investigational ARC-IM® targeted epidural neurostimulation system for restoring upright standing and functional walking in subacute and chronic spinal cord injury patients.
• Spineart SA Secures FDA 510(k) Clearance for BAGUERA® C Cervical Disc Surgical Instruments: Spineart SA obtained clearance (K262639) for its dedicated instrumentation suite facilitating precision positioning and keel preparation for cervical total disc arthroplasty.
• Corin Receives FDA 510(k) Clearance for the Icona Hip Stem: Corin, Ltd. secured 510(k) clearance (K261576) for the Icona Hip Stem, expanding its reconstructive hip arthroplasty franchise with advanced biomimetic stem geometry.

DAILY ANNOUNCEMENTS BY CATEGORY

Spine & Biologics Reimbursement

Medtronic — INFUSE® Bone Graft for TLIF Receives Medicare New Technology Add-on Payment (NTAP) Designation

• Summary: Medtronic Cranial & Spinal Technologies announced that the Centers for Medicare and Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for INFUSE® Bone Graft when utilized in transforaminal lumbar interbody fusion (TLIF) procedures, effective October 1, 2026. The designation provides incremental Medicare Fee-For-Service inpatient reimbursement when procedure costs exceed standard Medicare Severity Diagnosis-Related Group (MS-DRG) thresholds. This reimbursement approval follows the landmark FDA Premarket Approval (PMA) of INFUSE® for one- and two-level TLIF procedures following Breakthrough Device Designation, establishing economic viability for widespread hospital adoption.
• Key Details:
  • Device/System Name: INFUSE® Bone Graft (recombinant human bone morphogenetic protein-2 / rhBMP-2 on absorbable collagen sponge)
  • Status: CMS NTAP Approval (Effective Oct 1, 2026) / FDA PMA Approved (P000058/S043)
  • Clinical Significance: Eliminates hospital economic disincentives for utilizing proven osteoinductive growth factor biologics in TLIF, promoting solid arthrodesis while avoiding donor-site morbidity from autologous iliac crest bone graft harvesting.
• Original Source: Medtronic INFUSE® NTAP Designation Announcement — OrthoSpineNews

Surgical Robotics, AI & Spatial Computing

Stryker — Debuts FDA-Authorized SportSuite Vision for Apple Vision Pro with First Hip Arthroscopy Case

• Summary: Stryker announced the successful completion of the first surgical case utilizing SportSuite Vision on Apple Vision Pro at Duke Health, performed by Dr. Chad Mather III. SportSuite Vision received FDA De Novo authorization as the first intraoperative surgical application engineered for Apple Vision Pro spatial computing headsets. The software aggregates live high-definition arthroscopic video streams, HipCheck 3D intraoperative navigation, HipMap pre-operative planning, and volumetric CT slices into an interactive, heads-up spatial canvas manipulated seamlessly within the sterile surgical field.
• Key Details:
  • Device/System Name: SportSuite Vision for Apple Vision Pro
  • Status: FDA De Novo Authorization (DEN240032) / First Commercial Human Case Completed
  • Clinical Significance: Consolidates disparate physical OR video monitors into a customized, ergonomic heads-up spatial display, minimizing surgeon neck strain, preserving sterile field focus, and enhancing navigational precision during joint preservation procedures.
• Original Source: Stryker SportSuite Vision Clinical Debut Announcement — OrthoSpineNews

Spinal Neuromodulation & Clinical Trials

ONWARD Medical — First Patient Implanted in Landmark EIGER Feasibility Study for Spinal Cord Injury Mobility

• Summary: ONWARD Medical N.V. announced the first patient implantation in its landmark EIGER clinical feasibility study, evaluating the investigational ARC-IM® neurostimulation platform for restoring standing and functional walking. Conducted at Lausanne University Hospital (CHUV) in Switzerland under an Innosuisse grant, the EIGER trial is the first mobility protocol to enroll both subacute spinal cord injury patients (less than 6 weeks post-injury) and individuals with chronic motor paralysis. The therapy applies targeted, biomimetic electrical pulses directly to the lumbosacral dorsal root entry zones to re-engage dormant locomotor circuits.
• Key Details:
  • Device/System Name: ARC-IM® Implantable Neurostimulation System
  • Status: Clinical Feasibility Trial Initiation (EIGER Study / Investigational Device)
  • Clinical Significance: Accelerates motor rehabilitation by delivering synchronized, closed-loop epidural electrical stimulation during early neuroplasticity windows, aiming to restore voluntary weight-bearing and ambulatory independence.
• Original Source: ONWARD Medical EIGER Study Press Release — GlobeNewswire / Yahoo Finance

NEW FDA 510(k) & PMA CLEARANCE LISTING (PAST 24–48 HOURS)