FUTURTEC has announced that its ORTHBOT X® Knee Replacement Surgical Navigation and Positioning System has received certification under the European Union Medical Device Regulation (CE MDR).

The certification marks another regulatory step in the company’s overseas expansion. Following the international progress of its spinal surgery robotics portfolio, FUTURTEC is now advancing overseas development across both spine and joint surgery.

From Spine to Joint Surgery: Expanding the Orthopedic Robotics Portfolio

According to the company, its orthopedic robotics portfolio is built around the ORTHBOT platform and now covers both spinal and joint surgery.

FUTURTEC’s earlier ORTHBOT surgical robotic system received CE MDR certification in 2023, establishing a regulatory foundation for the company’s expansion in Europe. The latest certification for ORTHBOT X extends its certified portfolio into knee replacement.

With the addition of ORTHBOT X, FUTURTEC is expanding its orthopedic robotics portfolio from spine-focused applications into joint replacement, forming product lines across two major orthopedic surgical fields.

ORTHBOT X Covers Key Steps in Knee Replacement

ORTHBOT X is designed for use in total knee arthroplasty and is intended to support surgeons across key stages of the procedure.

According to information released by FUTURTEC, the system incorporates several workflow-related features.

Integrated workflow. ORTHBOT X is designed around major steps in knee replacement surgery, including preoperative planning, intraoperative positioning and execution assistance, reducing the need to switch between separate devices during the procedure.

Reduced dependence on conventional intramedullary instrumentation. The system uses navigation-based positioning to assist with bone preparation and is designed to reduce reliance on conventional intramedullary alignment techniques.

Adjustable surgical planning. Surgeons can modify parameters according to intraoperative conditions instead of relying solely on a fixed preoperative plan.

Soft-tissue balancing support. According to the company, ORTHBOT X can provide information intended to assist surgeons in evaluating soft-tissue balance during knee replacement.

The system is designed to integrate planning, navigation and intraoperative assistance into the knee replacement workflow.

Second CE MDR Certification Supports Overseas Expansion

ORTHBOT X is not FUTURTEC’s first product to receive European regulatory certification.

According to the company, its earlier ORTHBOT orthopedic surgical robot received an NMPA Class III medical device registration certificate in China in 2021 and subsequently obtained CE MDR certification in 2023.

The latest CE MDR certification for ORTHBOT X adds a joint replacement product to the company’s European-certified portfolio.

FUTURTEC describes its current overseas product strategy as covering both spine and joint surgery. The company is also continuing to expand international market development and cooperation.

For orthopedic surgical robot manufacturers, regulatory certification across different procedural platforms is an important prerequisite for broader commercialization. The latest certification gives FUTURTEC an additional product platform for its orthopedic robotics business in Europe.

About FUTURTEC

Founded in 2015, FUTURTEC focuses on the development of orthopedic surgical robots and related technologies.

According to company information, its business covers orthopedic surgical robotics, surgical navigation and related products, with products developed for spinal and joint surgery.

The company states that it operates an ISO 13485-compliant quality management system and continues to advance the development and commercialization of orthopedic surgical robotics products.

With ORTHBOT X now certified under CE MDR, FUTURTEC has added another regulatory foundation for expanding its orthopedic robotics portfolio in Europe.

August 21, 2026