Industry News

Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Zimmer Biomet to Preview the Next Era of Intelligent Orthopedic Surgery at AAHKS 2026: Reported by OrthoSpineNews, Zimmer Biomet Holdings, Inc. will preview an emerging technology category at the 2026 Annual Meeting of the American Association of Hip and Knee Surgeons (AAHKS) in Dallas, connecting surgical decisions to patient recovery and reducing procedural burden while maintaining surgeon control.
• OrthoArizona Surgeon First in the World to Perform Prophecy Incompass Total Ankle Replacement: Reported by OrthoSpineNews, Dr. Jason Patterson completed the first three clinical cases worldwide using Stryker's Prophecy Incompass preoperative CT-guided 3D-printed resection guides paired with an intraoperatively modular total ankle replacement system.
• Vivex Biologics' VIA Disc® NP Meets Primary Endpoint in Pivotal, Sham-Controlled ASCEND Trial Published in Journal of Clinical Medicine: Reported by Orthopedics This Week, 60% of participants treated with VIA Disc® NP achieved clinically meaningful back pain relief at six months compared with 1.6% of sham-treated participants (p < 0.001) in the peer-reviewed ASCEND trial for chronic lumbar discogenic pain.
• Paragon 28, Inc. Obtains 510(k) Clearance for APEX 3D S Diamond Tibia: Paragon 28, Inc. received FDA 510(k) clearance (K261120) for its APEX 3D S Diamond Tibia component indicated for total ankle arthroplasty.
• Encore Medical L.P. Obtains 510(k) Clearance for AltiVate Reverse® Glenosphere with RAVN™ Technology: Encore Medical L.P. secured FDA 510(k) clearance (K263086) for its AltiVate Reverse® Glenosphere with RAVN™ porous titanium technology for reverse shoulder reconstruction.

DAILY ANNOUNCEMENTS BY CATEGORY

Surgical Robotics, AI & Navigation

Zimmer Biomet Holdings, Inc.: Zimmer Biomet to Preview the Next Era of Intelligent Orthopedic Surgery at AAHKS 2026

• Summary: Zimmer Biomet Holdings, Inc. announced its plans to host a featured symposium and booth discussions to reveal a new vision for intelligent orthopedic surgery at the 2026 Annual Meeting of the American Association of Hip and Knee Surgeons (AAHKS), taking place November 5-8 in the Dallas area. At its symposium on November 6, Zimmer Biomet will preview an emerging technology category that looks beyond individual robotic capabilities toward a more intelligent, connected approach to orthopedic care designed around surgeon expertise, judgment, and control. The company will showcase its ROSA Knee with OptimiZe, ROSA Hip CT, TMINI Miniature Robotic System, OrthoGrid HipAI, and Persona Knee System including the OsseoTi Keel Tibia and SoluTion PPS Femur.
• Key Details:
  • Device/System Name: ROSA Knee with OptimiZe, ROSA Hip CT, TMINI Miniature Robotic System, OrthoGrid HipAI, and Persona Knee System
  • Status: Featured Symposium and Technology Preview (AAHKS 2026)
  • Clinical Significance: Transitions digital orthopaedics from isolated robotic execution toward connected, intelligent surgical workflows that capture intraoperative decisions, link technical execution directly to patient recovery curves, and reduce procedural and cognitive burden while maintaining surgeon operative control.
• Original Source: OrthoSpineNews

Trauma & Extremities

Stryker / OrthoArizona: OrthoArizona Surgeon First in the World to Perform Prophecy Incompass Total Ankle Replacement

• Summary: Dr. Jason Patterson, an orthopedic surgeon with OrthoArizona, is the first surgeon in the world to perform total ankle replacement surgery using Stryker's new Prophecy Incompass patient-specific instrumentation. Dr. Patterson completed three procedures in July 2026. The Prophecy system uses a patient's own CT scan to build a custom, 3D-printed surgical guide before the operation begins, pairing with Stryker's Incompass total ankle system to give surgeons the intraoperative flexibility to switch between stemmed or pegged implant configurations if patient anatomy dictates once the joint is exposed.
• Key Details:
  • Device/System Name: Prophecy Incompass Patient-Specific Instrumentation and Total Ankle System
  • Status: First Commercial Cases Worldwide Completed (Reported October 2026)
  • Clinical Significance: Combines preoperative CT-based 3D-printed patient-specific resection guides with intraoperative implant modularity (stemmed versus pegged configurations), enhancing coronal alignment precision and implant fixation while shortening operative time in complex total ankle arthroplasty.
• Original Source: OrthoSpineNews

Spine & Orthobiologics

Vivex Biologics, Inc.: Vivex Biologics' VIA Disc® NP Meets Primary Endpoint in Pivotal, Sham-Controlled ASCEND Trial Published in Journal of Clinical Medicine

• Summary: Vivex Biologics, Inc., a leader in developing and delivering advanced allograft solutions, announced that results from its pivotal ASCEND study of VIA Disc® NP have been published in Journal of Clinical Medicine. The trial met its primary endpoint: 60% of participants treated with VIA Disc NP achieved clinically meaningful back pain relief at six months, compared with 1.6% of sham-treated participants (p < 0.001). At three months, the last visit before non-responding sham participants were permitted to cross over to treatment, 53% of VIA Disc® NP participants and 5% of sham participants achieved clinically meaningful relief under fully blinded conditions (p < 0.001). The publication establishes VIA Disc® NP as the first intradiscal allograft demonstrating success in a gold-standard sham-controlled clinical trial for chronic lumbar discogenic pain.
• Key Details:
  • Device/System Name: VIA Disc® NP Intradiscal Nucleus Pulposus Allograft
  • Status: Pivotal Level 1 Sham-Controlled Trial Publication (Journal of Clinical Medicine)
  • Clinical Significance: Establishes Level 1 clinical evidence demonstrating superior, statistically significant relief of chronic lumbar discogenic pain over sham intervention, validating minimally invasive intradiscal allograft augmentation as an anatomical preservation therapy prior to surgical fusion.
• Original Source: Orthopedics This Week

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.