Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Centinel Spine Receives FDA Approval for Two-Level Use of prodisc® C Nova Cervical Total Disc Replacement: Reported by Orthopedics This Week, Centinel Spine secured U.S. FDA approval for two-level indications of the prodisc® C Nova cervical total disc replacement device, expanding motion-preserving arthroplasty options with anatomically tailored low-profile keels within its Match-The-Disc™ portfolio.
• Stryker Launches Sonopet® 3 Platform for Ultrasonic Bone and Soft Tissue Removal: Reported by OrthoSpineNews, Stryker commercially launched its next-generation Sonopet® 3 ultrasonic surgical console following FDA 510(k) clearance, combining RISE connected OR workflows and Pulse Control technology for precise tissue resection in complex spine and neurosurgery.
• Keck Medicine of USC Evaluates Investigational Cartilage-Preserving Injection CX-011 in Knee Osteoarthritis Clinical Trial: Reported by Orthopedics This Week, Keck Medicine of USC initiated a Phase 1 randomized, double-blind clinical trial evaluating CX-011, a novel biologic designed to arrest inflammatory cartilage breakdown via GP130 receptor signaling modulation as a potential disease-modifying osteoarthritis drug.
• TDM Large Bone Plate and Screw System Cleared: Tdm Co., Ltd. received FDA 510(k) clearance (K261611) for the TDM Large Bone Plate and Screw System indicated for anatomical plate fixation of diaphyseal and metaphyseal long bone fractures.
• ZSAlign Cervical Interbody System Cleared: ZSFab, Inc. received FDA 510(k) clearance (K263113) for the ZSAlign Cervical Interbody System featuring 3D-printed porous titanium for cervical intervertebral body fusion.

DAILY ANNOUNCEMENTS BY CATEGORY

Spine & Orthobiologics

Centinel Spine, LLC — Centinel Spine Receives FDA Approval for Two-Level Use of prodisc® C Nova Cervical Total Disc Replacement

• Summary: Centinel Spine announced U.S. Food and Drug Administration (FDA) approval for two-level use of the prodisc® C Nova cervical total disc replacement (TDR) device, joining prodisc C Vivo and prodisc C SK as three distinct cervical implants approved for one- and two-level indications. Featuring flat endplates with low-profile keels engineered for specific anatomical variations, the device incorporates prodisc CORE ball-and-socket kinematic technology, expanding surgical options within the company's Match-The-Disc™ portfolio.
• Key Details:
  • Device/System Name: prodisc® C Nova Cervical Total Disc Replacement Device
  • Status: FDA Approved (Two-Level Cervical TDR Indication Expansion)
  • Clinical Significance: Broadens motion-preserving arthroplasty options for multi-level cervical disc disease, offering surgeons intraoperative flexibility to match implant keel geometry to patient anatomy at adjacent cervical levels without compromising kinematic stability.
• Original Source: Orthopedics This Week

Surgical Robotics, AI & Navigation

Stryker — Stryker Launches Sonopet® 3 Platform for Ultrasonic Bone and Soft Tissue Removal

• Summary: Stryker announced the commercial launch of Sonopet® 3, its next-generation ultrasonic bone and soft tissue removal console, following U.S. FDA 510(k) clearance. Developed through extensive surgeon collaboration, the platform features the Reimagined Integrated Surgical Experience (RISE) for connected OR workflows and proprietary Pulse Control technology for regulated resection across varying tissue densities.
• Key Details:
  • Device/System Name: Sonopet® 3 Ultrasonic Tissue Removal System
  • Status: FDA 510(k) Cleared & Commercial Launch
  • Clinical Significance: Delivers enhanced power, improved ergonomic handpiece design, and fine-tuned ultrasonic oscillation to resect dense bony anatomy while preserving critical neurovascular and dural structures during complex spinal decompression and skull-base procedures.
• Original Source: OrthoSpineNews

Joint Reconstruction

Keck Medicine of USC — Keck Medicine of USC Evaluates Investigational Cartilage-Preserving Injection CX-011 in Knee Osteoarthritis Clinical Trial

• Summary: Keck Medicine of USC has launched an early-phase, randomized, double-blind clinical trial evaluating the safety, tolerability, and structural cartilage-protective effects of CX-011, a novel single-injection biologic developed at the Keck School of Medicine. Led by orthopaedic surgery chair Jay R. Lieberman, MD, and stem cell researcher Denis Evseenko, MD, PhD, the trial investigates whether modulating GP130 receptor signaling can arrest inflammatory cartilage degradation in patients with knee osteoarthritis.
• Key Details:
  • Device/System Name: CX-011 Investigational Intra-Articular Therapy
  • Status: Phase 1 Randomized Double-Blind Clinical Trial
  • Clinical Significance: Explores a potential disease-modifying osteoarthritis drug (DMOAD) mechanism designed to interrupt destructive post-inflammatory signaling without entirely silencing normal GP130 immune and stem cell functions, targeting biological preservation of articular cartilage to delay or avert total knee replacement.
• Original Source: Orthopedics This Week

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.