Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyx™ Extending Compromised Bone Platform Beyond Pelvis: Reported by OrthoSpineNews, SI-BONE secured FDA 510(k) clearance for the iFuse Granite Onyx™ System, expanding its breakthrough-designated 3D-printed osseointegration platform to upper and lower instrumented vertebrae (UIV and LIV) to prevent screw loosening in compromised bone without cement augmentation.
• VB Spine Awarded FDA Breakthrough Device Designation for ScolimiR-3D Predictive AIS Blood Test: Reported by OrthoSpineNews, VB Spine announced FDA Breakthrough Device Designation for ScolimiR-3D, a first-in-class in vitro diagnostic assay profiling six circulating microRNAs to predict curve progression risk in adolescent idiopathic scoliosis with 100% sensitivity and specificity in clinical validation.
• Chest Wall Innovations Commercially Launches PC Fix Rib Fixation System Across U.S. Trauma Centers: Reported by OrthoSpineNews, Chest Wall Innovations introduced its PC Fix Rib Fixation System commercially for surgical stabilization of rib fractures (SSRF), providing trauma surgeons with the first intrathoracic PEEK construct alongside titanium options to simplify fracture reduction and minimize hardware prominence.
• Corin Unity Total Knee System Cementless CR Femur Cleared: Corin, Ltd. obtained FDA 510(k) clearance (K261275) for its Unity Total Knee System cementless cruciate-retaining (CR) femoral implant for primary total knee arthroplasty.
• Nvision Biomedical Technologies EnHAnce PEEK Bunion System Cleared: Nvision Biomedical Technologies, Inc. received FDA 510(k) clearance (K262098) for the EnHAnce PEEK Bunion System indicated for hallux valgus correction and osteotomy fixation in foot and ankle surgery.

DAILY ANNOUNCEMENTS BY CATEGORY

Spine & Orthobiologics

SI-BONE, Inc. — SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyx™ Extending Its Compromised Bone Franchise Beyond the Pelvis

• Summary: SI-BONE announced U.S. FDA 510(k) clearance for the iFuse Granite Onyx™ System, marking the company's first breakthrough-designated platform engineered specifically for compromised bone outside the pelvis. Featuring a bone-density-specific surface and targeted thread geometry, Onyx addresses construct loosening at the upper and lower instrumented vertebrae (UIV and LIV)—a complication affecting up to 27% of adult spinal deformity constructs in osteoporotic bone.
• Key Details:
  • Device/System Name: iFuse Granite Onyx™ System
  • Status: FDA 510(k) Cleared (FDA Breakthrough Device Designated platform)
  • Clinical Significance: Mitigates junctional screw loosening and early construct failure at UIV and LIV anchor points in adult deformity and complex fusion constructs, providing immediate mechanical stability and rapid osseointegration in compromised bone without requiring polymethylmethacrylate (PMMA) cement augmentation.
• Original Source: OrthoSpineNews

Corporate, M&A & Regulatory

VB Spine LLC — VB Spine Announces FDA Breakthrough Device Designation for New Blood Test Designed to Identify Patients at Risk for Scoliosis Progression

• Summary: VB Spine received FDA Breakthrough Device Designation for ScolimiR-3D, the first predictive in vitro diagnostic blood test developed to stratify disease progression risk in adolescent idiopathic scoliosis (AIS). Developed in partnership with Dr. Alain Moreau at CHU Sainte-Justine and Université de Montréal, the assay profiles six circulating microRNAs via standard phlebotomy, having demonstrated 100% sensitivity and specificity in validation testing to predict severe spinal curve progression.
• Key Details:
  • Device/System Name: ScolimiR-3D MicroRNA Predictive Diagnostic Assay
  • Status: FDA Breakthrough Device Designation Granted
  • Clinical Significance: Transforms scoliosis management from reactive radiographic monitoring to biology-based proactive risk stratification, empowering spine surgeons and orthotists to implement early, customized bracing regimens for high-risk patients while sparing low-risk adolescents unnecessary overtreatment and serial ionizing radiation exposure.
• Original Source: OrthoSpineNews

Trauma & Extremities

Chest Wall Innovations, Inc. — Chest Wall Innovations Announces Commercial Launch of the PC Fix Rib Fixation System

• Summary: Chest Wall Innovations commercially launched its PC Fix Rib Fixation System across U.S. trauma centers following multiple successful clinical procedures since receiving FDA 510(k) clearance. Designed for surgical stabilization of rib fractures (SSRF), PC Fix is manufactured in both PEEK (polyether ether ketone) and titanium configurations, establishing the first and only intrathoracic PEEK rib fixation solution available for chest wall reconstruction.
• Key Details:
  • Device/System Name: PC Fix Rib Fixation System
  • Status: Commercial Launch (Following FDA 510(k) Clearance)
  • Clinical Significance: Expands surgical options for flail chest and displaced rib fracture patterns in alignment with American College of Surgeons SSRF guidelines, offering an intrathoracic radiolucent PEEK construct that simplifies anatomical reduction and reduces palpable hardware irritation compared to conventional extrathoracic metallic plates.
• 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.