Industry News

Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• FX Shoulder Solutions Achieves EU MDR Certification for Humelock Reversed® Shoulder System: Reported by OrthoSpineNews, FX Shoulder Solutions, Inc. announced that its Humelock Reversed shoulder system achieved EU MDR 2017/745 certification, supported by post-market clinical follow-up data across 138 patients followed for at least 3 years showing a 0.72% revision rate for instability and zero implant migration or subsidence.
• Total Joint Orthopedics Launches Klassic® Infection Spacer System with Dual Indication for Two-Stage PJI Revision: Reported by OrthoSpineNews, Total Joint Orthopedics, Inc. debuted the Klassic Infection Spacer System (KISS) at AAHKS 2026, receiving clearance for temporary implantation up to 180 days in two-stage PJI procedures and permanent reconstruction, running on single-tray Klassic ONE instrumentation for up to 90% of cases.
• Surgical Planning Associates Expands HipInsight System Open Platform 3D Planning to Over 35 Total Hip Systems: Reported by OrthoSpineNews, Surgical Planning Associates expanded its HipInsight System preoperative 3D planning library to over 35 total hip systems, adding five implant systems and showcasing enhanced Smart Fluoro verification at AAHKS 2026.
• Globus Medical, Inc. Obtains 510(k) Clearance for ANTHEM™ Fracture System: Globus Medical, Inc. received FDA 510(k) clearance (K262779) for its ANTHEM fracture fixation bone plate system under 21 CFR 888.3030.
• Alphatec Spine, Inc. Obtains 510(k) Clearance for Calibrate MAX and CCX Interbody Systems: Alphatec Spine, Inc. secured FDA 510(k) clearance (K262646) for its Calibrate MAX and CCX lumbar intervertebral fusion device systems under 21 CFR 888.3080.

DAILY ANNOUNCEMENTS BY CATEGORY

Trauma & Extremities

FX Shoulder Solutions, Inc.: FX Shoulder Solutions Achieves EU MDR Certification for Humelock Reversed® Shoulder System

• Summary: FX Shoulder Solutions, Inc. announced that its Humelock Reversed shoulder system has achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745), marking a key regulatory milestone in harmonizing its product portfolio across international markets. Supported by post-market clinical follow-up (PMCF) data across 138 patients followed for at least 3 years, the system demonstrated a 0.72% revision rate for instability (1 of 138), a 1.45% device-related revision rate (2 of 138), an overall 2.17% revision rate (3 of 138), and zero reported implant migration or subsidence.
• Key Details:
  • Device/System Name: Humelock Reversed® Shoulder System
  • Status: EU MDR 2017/745 Certification
  • Clinical Significance: Validates reverse shoulder arthroplasty stability with long-term PMCF evidence (0.72% instability revision rate, 1.45% device-related revision rate, zero subsidence across 138 patients followed for at least 3 years) and establishes regulatory continuity for revised instrumentation and modular implant options across global surgical practices.
• Original Source: OrthoSpineNews

Joint Reconstruction

Total Joint Orthopedics, Inc.: Total Joint Orthopedics Launches Klassic® Infection Spacer System with Dual Indication for Two-Stage PJI Revision

• Summary: Total Joint Orthopedics, Inc. (TJO) announced the commercial launch of the Klassic Infection Spacer System (KISS), expanding its Klassic Revision Knee platform for periprosthetic joint infection (PJI) management. Debuting at the AAHKS 2026 Annual Meeting, KISS is cleared with a dual indication for both temporary implantation (up to 180 days) during two-stage PJI procedures and permanent TKA reconstruction. Replacing molded cement spacers with permanent implant biomaterials (Aurum/Ti, CoCr, and UHMWPE) and an Ultra-PS ultracongruent articulating insert, KISS preserves joint motion and stability while running on single-tray Klassic ONE instrumentation for up to 90% of cases.
• Key Details:
  • Device/System Name: Klassic® Infection Spacer System (KISS)
  • Status: Commercial Launch (AAHKS 2026) / Dual-Indication FDA Clearance
  • Clinical Significance: Replaces molded antibiotic cement spacers with permanent biomaterials (Aurum/Ti, CoCr, UHMWPE) and Ultra-PS ultracongruent insert, preserving functional joint kinematics and soft-tissue tension between two-stage PJI revisions for up to 180 days while running on single-tray Klassic ONE instrumentation for up to 90% of cases.
• Original Source: OrthoSpineNews

Surgical Robotics, AI & Navigation

Surgical Planning Associates: Surgical Planning Associates Expands HipInsight System Open Platform 3D Planning to Over 35 Total Hip Systems

• Summary: Surgical Planning Associates (SPA) announced the addition of five implant systems to the 3D preoperative planning library of its HipInsight System, expanding the open platform to more than 35 total hip arthroplasty systems. The expansion incorporates additional femoral and acetabular components from Enovis, Maxx Orthopedics, MicroPort Orthopedics, Smith+Nephew, and Zimmer Biomet, including multiple triple-taper stem designs. Showcased at AAHKS 2026, the updated platform pairs preoperative anatomic pelvic tilt modeling with enhanced Smart Fluoro intraoperative imaging to verify implant positioning without locking surgeons into proprietary implant hardware.
• Key Details:
  • Device/System Name: HipInsight System®
  • Status: Open-Platform Expansion (AAHKS 2026)
  • Clinical Significance: Enables implant-agnostic 3D CT surgical planning and augmented fluoroscopic verification across anterior and superior approaches, optimizing acetabular cup orientation and spinopelvic alignment across more than 35 total hip arthroplasty systems without locking surgeons into proprietary implant hardware.
• Original Source: OrthoSpineNews

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.