Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• New STIMULAN® Biofilm Data: Biocomposites presented new data at EBJIS-MSIS 2026 demonstrating that STIMULAN® beads loaded with combination antibiotics eradicate Staphylococcus aureus biofilms across titanium, stainless steel, and polyethylene implant surfaces.
• Launch of MyFit Digital Suite: restor3d launched its MyFit Digital Suite, connecting patients to interactive 3D models of their personalized implants preoperatively while systematically tracking PROMs in a longitudinal patient-specific registry.
• rhNELL-1 Spinal Fusion Trial Expansion: Bone Biologics Corporation doubled participating hospital sites in Australia for its first-in-human pilot trial evaluating NB1 (rhNELL-1 + DBM) for single-level TLIF in degenerative disc disease.
• FRAXION Plate and Screw System Cleared: Ortler Global Tibbi Gerecler Anonim Sirketi received FDA 510(k) clearance (K261830) for its comprehensive plate and bone screw system for traumatic skeletal fixation.
• HOPKINS Telescopes for Arthroscopy Cleared: Karl Storz SE & CO. KG received FDA 510(k) clearance (K254103) for high-definition rod-lens arthroscopic visualization.

DAILY ANNOUNCEMENTS BY CATEGORY

Infection Management & Biomaterials

Biocomposites — New STIMULAN® Biofilm Eradication Data Presented at EBJIS-MSIS 2026

• Summary: Biocomposites announced it will present new scientific data and host an industry symposium at the 44th Annual Meeting of the European Bone & Joint Infection Society (EBJIS-MSIS 2026) in Porto, Portugal. The in-vitro research evaluates the antibacterial efficacy of STIMULAN® calcium sulfate beads loaded with combination antibiotic regimens against Staphylococcus aureus biofilms, demonstrating eradication of early biofilms and significant reductions in mature biofilms across titanium, stainless steel, and polyethylene implant surfaces.
• Key Details:
  • Device/System Name: STIMULAN® Calcium Sulfate Antibiotic Carrier Matrix
  • Status: Scientific Symposium & Clinical Data Presentation (European MDR Certified)
  • Clinical Significance: Provides rigorous evidence that locally delivered combination antibiotic therapy via bioabsorbable calcium sulfate eradicates biofilm across all major orthopaedic implant surfaces, improving treatment strategies for complex periprosthetic joint infections (PJI) while eliminating secondary surgical retrieval.
• Original Source: OrthoSpineNews

Joint Reconstruction & Surgical Technology

restor3d — Launch of MyFit by restor3d Digital Suite for Personalized Orthopedic Implants

• Summary: restor3d announced the launch of its MyFit by restor3d Digital Suite, an interactive patient engagement ecosystem designed to give patients visibility into their personalized 3D-printed orthopedic implant journey. The suite includes an interactive patient portal allowing shoulder and foot/ankle patients to view 3D models of their custom implants preoperatively, while providing automated milestone tracking for hip and knee arthroplasty patients and integrating directly with the prospective restor3d Patient-Specific Registry.
• Key Details:
  • Device/System Name: MyFit by restor3d Digital Suite & Patient-Specific Registry
  • Status: Commercial Product Launch
  • Clinical Significance: Enhances patient engagement and preoperative education through custom 3D implant visualization while capturing longitudinal patient-reported outcome measures (PROMs) to advance clinical evidence for personalized additive-manufactured joint replacements.
• Original Source: Orthopedics This Week

Spine & Orthobiologics

Bone Biologics Corporation — Expansion of NB1 rhNELL-1 Pilot Clinical Trial Sites for TLIF Spinal Fusion

• Summary: Bone Biologics announced that six hospital centers in Australia are now participating in its first-in-human randomized pilot clinical trial of NB1, doubling its participating centers. The prospective, parallel-group trial evaluates the safety and preliminary fusion success of NB1—a recombinant human NELL-1 protein (rhNELL-1) combined with demineralized bone matrix—in adult patients undergoing transforaminal lumbar interbody fusion (TLIF) for single-level degenerative disc disease.
• Key Details:
  • Device/System Name: NB1 rhNELL-1 Bone Graft Substitute
  • Status: Clinical Trial Expansion (Pilot Clinical Study)
  • Clinical Significance: Doubles patient recruitment capacity to complete enrollment by year-end 2026 for a targeted osteoinductive growth factor platform, paving the way for FDA pivotal trials and offering a potentially safer regenerative alternative to high-dose BMP-2 in lumbar fusion.
• 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.