Industry News

Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Medacta Launches the Mfinity Femoral System at AAHKS 2026, Combining Versatile Implant Design and Efficient Instrumentation: Reported by Orthopedics This Week, Medacta Group SA announced the full commercial release of the Mfinity Femoral System in the United States at the AAHKS 2026 Annual Meeting, featuring collared and collarless options, optimized distal geometry for narrow Dorr Type A canals, and single-tray modular instrumentation.
• Medartis Reports Accelerating U.S. Adoption Momentum for TOUCH® Thumb Joint Prosthesis: Reported by OrthoSpineNews, Medartis Holding AG surpassed 2,000 U.S. procedures for the TOUCH® dual-mobility thumb carpometacarpal prosthesis by October 2026, pacing toward 3,000 cases by year-end as a motion-preserving alternative to trapeziectomy.
• Revision Open Reduction Maintains Joint Stability in Pediatric Syndromic Hip Dysplasia: Reported by Healio Orthopedics, a Children's Hospital Los Angeles (CHLA) study presented at AAP 2026 demonstrated that revision surgery can successfully rescue failed primary open reductions and maintain durable joint reduction in pediatric syndromic hyperlaxity hip dysplasia.
• restor3d, inc. Obtains 510(k) Clearance for Veritas Shoulder System: restor3d, inc. received FDA 510(k) clearance (K263421) for its Veritas Shoulder System indicated for reverse shoulder arthroplasty.
• Smith & Nephew, Inc. Obtains 510(k) Clearance for Q-FIX KNOTLESS All-Suture Anchor: Smith & Nephew, Inc. secured FDA 510(k) clearance (K263348) for its Q-FIX KNOTLESS All-Suture Anchor indicated for nondegradable soft tissue fixation.

DAILY ANNOUNCEMENTS BY CATEGORY

Joint Reconstruction

Medacta Group SA: Medacta Launches the Mfinity Femoral System at AAHKS 2026, Combining Versatile Implant Design and Efficient Instrumentation

• Summary: Medacta Group SA announced the full commercial release of the Mfinity Femoral System in the United States at the 2026 Annual Meeting of the American Association of Hip and Knee Surgeons (AAHKS). Designed to accommodate diverse patient anatomies and minimally invasive surgical approaches, the system features a metaphyseal-filling stem available in collared and collarless options, progressive neck length and collar variation, and a reduced distal geometry specifically tailored for narrow femoral canals, including Dorr Type A. The Mfinity L option provides a longer ream-and-broach cementless design, while single-tray modular instrumentation allows seamless intraoperative conversion between cementless and cemented stems without opening an additional set, reducing the operating room footprint for ambulatory surgery centers.
• Key Details:
  • Device/System Name: Mfinity™ Femoral System and Mfinity™ L
  • Status: Full U.S. Commercial Release (AAHKS 2026)
  • Clinical Significance: Accommodates diverse and narrow femoral anatomies (Dorr Type A) with streamlined single-tray instrumentation that enables seamless intraoperative conversion between cementless and cemented fixation, reducing instrument tray burden in ambulatory surgery centers and integrating with NextAR™ Hip AR navigation and MyHip® digital planning.
• Original Source: Orthopedics This Week

Trauma & Extremities

Medartis Holding AG: Medartis Reports Accelerating U.S. Adoption Momentum for TOUCH® Thumb Joint Prosthesis

• Summary: Medartis Holding AG reported accelerated momentum in its U.S. extremities business driven by rapid surgeon adoption of Keri Medical's TOUCH prosthesis for thumb carpometacarpal (CMC 1) osteoarthritis (rhizarthrosis). The company announced that more than 2,000 TOUCH procedures were completed in the United States by October 2026, pacing toward approximately 3,000 cases by year-end 2026. Building on a decade of clinical track record in Europe, the dual-mobility design offers hand surgeons a motion-preserving alternative to trapeziectomy that restores native thumb column height, restores pinch strength, and accelerates functional recovery.
• Key Details:
  • Device/System Name: TOUCH® CMC 1 Thumb Joint Prosthesis
  • Status: Commercial Rollout Milestone (Surpassed 2,000 U.S. Procedures)
  • Clinical Significance: Offers hand and upper extremity surgeons a dual-mobility, motion-preserving anatomical alternative to trapeziectomy for carpometacarpal osteoarthritis, maintaining thumb ray length, stabilizing pinch grip strength, and facilitating faster postoperative rehabilitation.
• Original Source: OrthoSpineNews

Clinical Evidence & Registry

Children's Hospital Los Angeles (CHLA): Revision Open Reduction Maintains Joint Stability in Pediatric Syndromic Hip Dysplasia

• Summary: In a single-center retrospective study presented at the American Academy of Pediatrics (AAP) National Conference & Exhibition in San Diego, Dr. Robert M. Kay and colleagues from Children's Hospital Los Angeles evaluated surgical outcomes in children with syndromic hyperlaxity-associated developmental dysplasia of the hip (DDH) who underwent open reduction. In the cohort, 46.2% underwent isolated open reduction, with the remaining patients requiring an osteotomy in conjunction with open reduction (23.1% femoral, 15.4% pelvic, 15.4% combined pelvic and femoral). Although redislocation occurred in four hips (30.7%) and subluxation in two (15.4%), revision surgery successfully achieved and maintained joint reduction in all revised patients, demonstrating that revision surgery can successfully rescue failed primary reductions in complex syndromic pediatric hips.
• Key Details:
  • Device/System Name: Tailored Open Reduction & Pelvic/Femoral Osteotomy Protocols
  • Status: Clinical Evidence Presented at AAP 2026 National Conference
  • Clinical Significance: Refutes historical perceptions that revision surgery for redislocation after open reduction in syndromic hyperlaxity DDH leads to universally poor outcomes, demonstrating that meticulous patient-tailored surgical planning and revision intervention can achieve durable concentric joint reduction.
• Original Source: Healio Orthopedics

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.