Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Zimmer Biomet and THINK Surgical Extend Exclusive Distribution Agreement for Handheld TMINI Miniature Robotic System: Reported by OrthoSpineNews, Zimmer Biomet Holdings and THINK Surgical announced a multi-year extension of their exclusive distribution and supply agreement for the wireless, handheld TMINI® Miniature Robotic System integrated with the Persona Knee System for total knee arthroplasty (TKA).
• Providence Medical Technology Receives FDA 510(k) Clearance for CORUS™ PCSS 3D-T Segmental Fusion Platform: Reported by OrthoSpineNews, Providence Medical Technology secured FDA 510(k) clearance for the CORUS™ PCSS 3D-T posterior cervical fixation device featuring 3D-printed porous titanium ahead of its commercial debut at NASS 2026.
• Advita Engineers Equinoxe® Scapula Reconstruction System to Address Post-Arthroplasty Acromial Fractures: Analyzed by BONEZONE, design teams detailed the development of the Equinoxe® Scapula Reconstruction System, the first dedicated orthopaedic plating platform engineered to treat acromial and scapular spine fractures following reverse total shoulder arthroplasty.
• Response Ortho Smart Fixator — Hexapod System Cleared: Response Ortho Solutions, LLC received FDA 510(k) clearance (K263083) for the Response Ortho Smart Fixator — Hexapod System indicated for multi-axial circular external fixation and deformity correction.
• OsteoCentric Technologies Cannulated and Solid Fasteners with Nuts Cleared: OsteoCentric Technologies received FDA 510(k) clearance (K263116) for Cannulated and Solid Fasteners with Nuts indicated for trauma and spine mechanical bone integration.

DAILY ANNOUNCEMENTS BY CATEGORY

Surgical Robotics, AI & Navigation

Zimmer Biomet / THINK Surgical — Zimmer Biomet and THINK Surgical Extend Exclusive Distribution Agreement for Handheld TMINI Miniature Robotic System

• Summary: Zimmer Biomet Holdings and THINK Surgical announced a multi-year extension of their Limited Exclusive Distribution and Supply Agreement. Under the extension, Zimmer Biomet will continue exclusive distribution of a customized version of THINK Surgical's wireless, handheld TMINI Miniature Robotic System integrated with the Persona Knee System for total knee arthroplasty (TKA).
• Key Details:
  • Device/System Name: TMINI® Miniature Robotic System
  • Status: Multi-Year Commercial Distribution & Supply Agreement Extension
  • Clinical Significance: Delivers a compact, wireless, handheld robotic cutting guide that seamlessly integrates into the Persona® Knee workflow, eliminating the bulky footprint and capital expense of large robotic consoles in high-throughput operating rooms and ambulatory surgery centers (ASCs).
• Original Source: OrthoSpineNews

Spine & Orthobiologics

Providence Medical Technology, Inc. — Providence Medical Technology Receives FDA 510(k) Clearance for CORUS™ PCSS 3D-T Segmental Fusion Platform

• Summary: Providence Medical Technology received FDA 510(k) clearance for its CORUS™ Posterior Cervical Stabilization System 3D-T (CORUS™ PCSS 3D-T), which will make its commercial debut at the NASS 2026 Annual Meeting. The nonsegmental posterior cervical fixation device incorporates 3D-printed porous titanium designed to mimic native cancellous bone architecture, serving as an adjunct to posterior cervical fusion.
• Key Details:
  • Device/System Name: CORUS™ Posterior Cervical Stabilization System 3D-T (CORUS™ PCSS 3D-T)
  • Status: FDA 510(k) Cleared / Commercial Debut at NASS 2026
  • Clinical Significance: Pairs sterile-packaged, single-use instrumentation with an osteoconductive porous titanium lattice engineered to optimize bone ingrowth and load distribution; builds upon Level 1 clinical evidence demonstrating superior fusion rates and significant reductions in 2-year revision surgery compared to anterior-alone fusion.
• Original Source: OrthoSpineNews

Trauma & Extremities

Advita Orthopedics — Advita Engineers Equinoxe® Scapula Reconstruction System to Address Post-Arthroplasty Acromial Fractures

• Summary: In an engineering and surgical technology analysis published by BONEZONE, design teams detailed the development of the Equinoxe® Scapula Reconstruction System, the first dedicated orthopaedic solution specifically engineered to treat acromial and scapular spine fractures and non-unions following reverse total shoulder arthroplasty (RTSA). The all-in-one system features pre-contoured plates, locking and compression screws, and specialized drill guides and plate hook crimpers supporting both single- and dual-plating techniques across variable scapular anatomy.
• Key Details:
  • Device/System Name: Equinoxe® Scapula Reconstruction System
  • Status: Specialized Trauma & Arthroplasty Reconstruction Plating Platform
  • Clinical Significance: Directly addresses one of the most frustrating and technically challenging complications in reverse shoulder arthroplasty (scapular spine and acromial stress fractures occurring in 1–5% of patients), restoring deltoid lever arm mechanics and patient function through rigid anatomical fixation without compromising glenosphere stability.
• Original Source: BONEZONE

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.