ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7

Zimmer Biomet Holdings, Inc. ZBH recently received approval from the Pharmaceutical and Medical Devices Agency (“PMDA”) in Japan for its iTaperloc Complete and iG7 Hip System with Iodine Technology that inhibits bacterial adhesion on the implant surface.

The earlier-than-expected approval in Japan further strengthens Zimmer Biomet's comprehensive portfolio of infection management solutions, including prevention, detection, primary and revision products. 

Importance of ZBH’s iTaperloc and iG7 Hip System

iTaperloc and iG7 combine the long-standing clinical heritage of the Taperloc Complete Hip System with the ease, efficiency, and performance of the G7 Acetabular System, enhanced by Iodine Technology. 

Implant-associated bacterial infection or Periprosthetic Joint Infection (“PJI”) remains one of the most common causes of revision and a challenging complication of total joint arthroplasty (TJA). PJI is estimated to occur in 1-2% of primary TJA procedures and can have serious consequences. 

In fact, the mortality rate associated with PJI approaches the 5-year mortality observed in breast cancer (11%) and far exceeds that of prostate cancer (1%). Zimmer Biomet’s iTaperloc Complete and iG7 Hip System with Iodine Technology helps address the issue of PJI after TJA.

Iodine is a biocompatible, essential body nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic. Iodine Technology applies iodine to the implant's surface during the manufacturing process to inhibit biofilm formation. 

Industry Prospects Favor ZBH

Per a report by the Grand View Research, the global orthopedic implants market size is anticipated to reach $32.47 billion by 2030, at a CAGR of 3.78% from 2025 to 2030. The market is driven by the growing prevalence of reduced bone density, weakened bones, and musculoskeletal disorders.

Other Updates by ZBH

Zimmer Biomet has entered into a definitive agreement to acquire Monogram Technologies Inc., an orthopedic robotics company. ZBH will acquire all outstanding shares of stock of Monogram for an upfront payment of $4.04 per share in cash, corresponding to an equity value of approximately $177 million and an enterprise value of approximately $168 million. 

Monogram's semi and fully autonomous robotic technologies are expected to add new and differentiated capabilities to expand Zimmer Biomet's flagship ROSA Robotics platform and broad suite of navigation and enabling technologies. The acquisition is expected to be completed at the end of 2025. 

Peer Update

In 2025, Stryker SYK introduced several key platforms, including the LIFEPAK 35 monitor/defibrillator, which builds on its heritage in emergency care and has already demonstrated strong early demand. Approved for Europe in late third-quarter 2025, the device enhances connectivity, portability, and usability, expanding Stryker’s footprint in the global defibrillator and monitoring market. Furthermore, the company continues to advance its pipeline, with key upcoming milestones including Mako 4 enhancements and the introduction of spine and shoulder robotic applications, both of which are expected to unlock entirely new growth verticals.

In July, Globus Medical GMED launched DuraPro with Navigation, a next-generation, oscillating system designed to safeguard delicate tissue. In addition to DuraPro, it launched Verzera, a navigated high-speed drill system integrated with the ExcelsiusGPS and ExcelsiusHub system. In the first quarter, the company expanded the Advanced Materials Science implant portfolio with the COHERE ALIF Spacer. Additionally, the launch of Modulus ALIF Blades marks an extension of its market-leading Modulus ALIF interbody spacer system.

In June, Orthofix Medical Inc. OFIX announced the global commercial launch of the TrueLok Elevate Transverse Bone Transport (“TBT”) System. TrueLok Elevate represents the first commercially available device in the United States with a patented design for use in the TBT procedure to provide a limb preservation treatment option for addressing bony or soft tissue deformities or defects, such as diabetic ulcers. The TrueLok Elevate System represents the latest addition to the company’s flagship product line, the TrueLok family of multiplanar external xators, including the TrueLok EVO and TL-HEX ring fixation systems.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research