Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Smith+Nephew Launches EVOS◊ PELVIC Plating System at OTA 2026 Annual Meeting: Reported by OrthoSpineNews, Smith+Nephew commercially introduced its anatomically pre-contoured EVOS◊ PELVIC Plating System at OTA 2026, expanding the EVOS platform with specialized posterior wall, quadrilateral surface, and pubic symphysis implants paired with dedicated cannulated screws and instrumentation to optimize reduction and rigid fixation in complex pelvic and acetabular disruptions.
• Johnson & Johnson Announces TREMFYA® Meets Primary and MRI Endpoints in Landmark Phase 4 STAR Study for Axial Psoriatic Arthritis: Reported by Orthopedics This Week, Johnson & Johnson announced topline results from the Phase 4 STAR trial establishing TREMFYA® (guselkumab) as the first and only IL-23 inhibitor demonstrating statistically significant improvements in axial symptoms alongside objective MRI-confirmed reduction in sacroiliac joint inflammation in biologic-naïve patients with axial psoriatic arthritis.
• AlloDirect Secures Pre-Seed Funding Led by M25 to Digitize Musculoskeletal Allograft & Biologics Procurement for ASCs: Reported by Orthopedics This Week, AlloDirect closed pre-seed financing led by M25 and appointed veteran technologist James A. Casavant as CTO to scale its digital ordering layer connecting ASCs directly to over 24,000 tissue bank allografts with real-time inventory visibility and UDI compliance tracking.
• Stryker Orthopaedics Triathlon® and Scorpio® Knee Systems Cleared: Howmedica Osteonics Corp. (Stryker Orthopaedics) received FDA 510(k) clearance (K261898) for its Triathlon® Knee System, Triathlon® Hinge Knee System, and Scorpio® Total Knee System indicated for primary and revision total knee arthroplasty.
• Globus Medical TRIVANCE™ Hip Stem Cleared: Globus Medical, Inc. secured FDA 510(k) clearance (K254043) for the TRIVANCE™ Hip Stem, an uncemented porous femoral stem indicated for total hip arthroplasty.

DAILY ANNOUNCEMENTS BY CATEGORY

Trauma & Extremities

Smith+Nephew — Smith+Nephew Launches EVOS◊ PELVIC Plating System at OTA 2026 Annual Meeting

• Summary: Smith+Nephew announced the commercial launch of its EVOS◊ PELVIC Plating System at the Orthopaedic Trauma Association (OTA) 2026 Annual Meeting, expanding the established EVOS plating portfolio into pelvic and acetabular trauma surgery. Developed in collaboration with leading trauma surgeons, the comprehensive system features anatomically pre-contoured plates for the posterior wall, quadrilateral surface, and pubic symphysis, paired with dedicated pelvic cannulated screws and specialized instruments to support reproducible plate-assisted reduction across complex fractures.
• Key Details:
  • Device/System Name: EVOS◊ PELVIC Plating System
  • Status: Commercial Launch (OTA 2026 Annual Meeting)
  • Clinical Significance: Addresses the demanding biomechanical and anatomical challenges of pelvic ring and acetabular disruptions, providing surgeons with pre-contoured implants and coordinated reduction tools that streamline intraoperative contouring, facilitate plate-assisted reduction, and maintain rigid fixation in both high-energy trauma and fragile osteoporotic bone.
• Original Source: OrthoSpineNews

Spine & Orthobiologics

Johnson & Johnson Innovative Medicine — Johnson & Johnson Announces TREMFYA® Meets Primary and MRI Endpoints in Landmark Phase 4 STAR Study for Axial Psoriatic Arthritis

• Summary: Johnson & Johnson announced topline results from the Phase 4 STAR study evaluating TREMFYA® (guselkumab), confirming it as the first and only IL-23 inhibitor to demonstrate statistically significant clinical improvements in axial symptoms alongside objective MRI-confirmed reduction of sacroiliac joint inflammation in biologic-naïve adults with active axial psoriatic arthritis. The prospective, double-blind trial met its primary endpoint of BASDAI improvement at Week 24 alongside major secondary endpoints (ASDAS-CRP and MRI sacroiliitis reduction) with an established safety profile.
• Key Details:
  • Device/System Name: TREMFYA® (guselkumab)
  • Status: Landmark Phase 4 Clinical Trial Topline Results (STAR Study)
  • Clinical Significance: Provides definitive prospective evidence that selective IL-23 inhibition achieves clinically meaningful relief of spinal pain and morning stiffness while objectively dampening sacroiliac inflammation on MRI, establishing a targeted biologic therapy for spine specialists managing axial spondyloarthritis with peripheral joint involvement.
• Original Source: Orthopedics This Week

Corporate, M&A & Regulatory

AlloDirect & M25 — AlloDirect Secures Pre-Seed Funding Led by M25 to Digitize Musculoskeletal Allograft & Biologics Procurement for ASCs

• Summary: AlloDirect announced a pre-seed financing round led by Chicago-based venture firm M25 and appointed healthcare supply chain software veteran James A. Casavant as Chief Technology Officer. The company's direct sourcing platform connects ambulatory surgery centers and hospital operating rooms to a unified catalog of over 24,000 allografts across six AATB-accredited tissue banks, capturing lot numbers and Unique Device Identification (UDI) data directly at order entry to eliminate procurement bottlenecks as musculoskeletal surgeries migrate to outpatient settings.
• Key Details:
  • Device/System Name: AlloDirect Digital Allograft & Biologics Procurement Platform
  • Status: Pre-Seed Financing & Technology Leadership Appointment
  • Clinical Significance: Solves multi-day procurement delays, inventory opacity, and post-hoc compliance tracking for human tissue in outpatient surgical centers, providing surgical teams and ASC administrators with transparent access, immediate inventory visibility, and end-to-end traceability for critical bone, tendon, and soft-tissue allografts.
• 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.