Industry News

Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Globus Medical Acquires Synaptive Medical to Expand Cranial Neurosurgery and Excelsius Ecosystem: Reported by OrthoSpineNews, Globus Medical, Inc. announced the completed acquisition of Synaptive Medical through a court-appointed receivership process, integrating surgical visualization, navigation, and planning with the Excelsius ecosystem.
• OSSTEC Secures $8 Million Financing for First-in-Human U.S. Cases of ASCENT® Cementless Partial Knee: Reported by Orthopedics This Week, OSSTEC closed an $8 million financing round led by EMBRYO Ventures to advance its 3D-printed biomimetic cementless partial knee and CLARITY instrumentation through FDA clearance toward U.S. clinical cases in the first half of 2027.
• OssDsign Launches Catalyst Commitment Fusion Warranty Backed by 88.4% Fusion Success in PROPEL Registry: Reported by Orthopedics This Week, OssDsign AB introduced a replacement warranty program for qualifying U.S. hospitals and ASCs using OssDsign Catalyst® nanosynthetic bone graft, supported by real-world registry evidence demonstrating an 88.4% fusion rate in complex spine patients.
• Pace Surgical Obtains 510(k) Clearance for Tempo Plating System: Pace Surgical secured FDA 510(k) clearance (K263407) for its Tempo bone fixation plating system under 21 CFR 888.3030.
• BAAT Medical Products B.V. Obtains 510(k) Clearance for GANNET®: BAAT Medical Products B.V. received FDA 510(k) clearance (K262184) for its GANNET proximal femoral fixation implant under 21 CFR 888.3030.

DAILY ANNOUNCEMENTS BY CATEGORY

Corporate, M&A & Regulatory

Globus Medical, Inc.: Globus Medical Acquires Synaptive Medical, Strengthening Its Position in Cranial Neurosurgery and Expanding Excelsius Ecosystem

• Summary: Globus Medical, Inc. announced the completed acquisition of Synaptive Medical through a court-appointed receivership process, deepening its presence in cranial neurosurgery and complex procedural solutions. Synaptive develops technologies spanning surgical visualization, navigation, robotic surgical planning, and point-of-care MRI. The transaction enables Globus Medical to expand beyond spine into integrated cranial procedures by coupling Synaptive's visualization and planning capabilities with the Excelsius ecosystem of enabling technologies.
• Key Details:
  • Device/System Name: Synaptive Surgical Planning, Visualization, Navigation, MRI & Excelsius Ecosystem
  • Status: Acquisition Completed (Court-Appointed Receivership Process)
  • Clinical Significance: Broadens robotic and digital surgery capabilities by uniting advanced cranial planning, digital visualization, and intraoperative imaging with the Excelsius ecosystem, providing surgeons with integrated procedural workflows across complex cranial and spine interventions.
• Original Source: OrthoSpineNews

Joint Reconstruction

OSSTEC: OSSTEC Closes $8 Million to Fund First-in-Human & U.S. Launch of ASCENT® Cementless Partial Knee and Advance Pipeline

• Summary: OSSTEC, an orthopaedic company developing 3D-printed cementless joint replacement implants, announced it has closed $8 million in funding to support first-in-human U.S. surgical cases of its ASCENT cementless fixed-bearing partial knee system. Led by EMBRYO Ventures with participation from Neovate Capital, New Wave Ventures, Oxford Technology Innovation Finance, and Empirical Ventures, the financing will advance ASCENT and its CLARITY instrumentation through FDA clearance toward U.S. clinical cases planned for the first half of 2027. Built on a proprietary 3D-printed biomimetic osseointegration platform, the system addresses unicompartmental knee arthroplasty without bone cement, aiming to eliminate cement-associated loosening and operative time while evaluating future integration with robotic platforms ahead of AAHKS 2026.
• Key Details:
  • Device/System Name: ASCENT® Cementless Partial Knee System & CLARITY Instrumentation
  • Status: Series A Financing ($8 Million) / Pre-FDA First-in-Human Preparation (AAHKS 2026)
  • Clinical Significance: Eliminates polymethylmethacrylate (PMMA) bone cement in unicompartmental knee arthroplasty through a 3D-printed biomimetic trabecular bone interface, mitigating cement extrusion risks and aseptic loosening while streamlining operating room workflow with CLARITY single-tray instrumentation.
• Original Source: Orthopedics This Week

Spine & Orthobiologics

OssDsign AB: OssDsign Launches Catalyst Commitment Fusion Warranty Program, Backed by Real-World Evidence of 88.4% Fusion Success in Complex Spine Patients

• Summary: OssDsign AB announced the U.S. commercial launch of the OssDsign Catalyst Commitment Fusion Warranty Program, providing replacement product kits to qualifying U.S. hospitals and ambulatory surgery centers if a nonunion occurs after on-label use in spinal fusion. The warranty program is backed by published real-world outcomes from the prospective multicenter PROPEL registry, in which OssDsign Catalyst nanosynthetic bone graft substitute achieved an 88.4% fusion success rate in real-world settings, including challenging patient cohorts where nearly half of patients presented with three or more comorbidities predisposing to pseudoarthrosis.
• Key Details:
  • Device/System Name: OssDsign Catalyst® Nanosynthetic Bone Graft Substitute
  • Status: Commercial Warranty Program Launch / PROPEL Registry Evidence Release
  • Clinical Significance: Provides clinical and financial risk-sharing for spine fusion procedures by pairing nanosynthetic calcium phosphate bone graft performance (88.4% CT-confirmed bridging bone in high-risk patients with multimorbidities) with a product replacement warranty against nonunion in U.S. hospitals and ASCs.
• 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.