SkyWalker Orthopedic Surgical Robot

SkyWalker (marketed domestically as Honghu/鸿鹄) achieved a milestone as the first and only Chinese-developed orthopedic surgical robot to obtain certifications from NMPA, FDA, CE, ANVISA, TGA, and Health Canada within a single product generation. The system has assisted in over 1,500 total knee arthroplasty procedures globally, with installations across five continents.

Product Overview

Developed by MicroPort NaviBot, a subsidiary of MicroPort MedBot, SkyWalker addresses the precision requirements of joint replacement surgery through CT-guided robotic arm assistance. The system received initial NMPA approval for total knee arthroplasty in April 2022, followed by FDA clearance in July 2022 and CE marking in December 2022.

In September 2023, NMPA approved expanded indications to include total hip arthroplasty, making SkyWalker China’s first domestically developed robotic system certified for both hip and knee joint replacement—a “hip-knee integrated” platform.

Key Features

Certified across NMPA, FDA, CE, TGA, ANVISA, and Health Canada, SkyWalker is the only Chinese orthopedic robot to hold concurrent approvals in all six major regulatory jurisdictions for joint replacement surgery.

• CT-Guided Navigation: Preoperative CT scans generate 3D joint models for surgical planning
• Personalized Planning: Patient-specific prosthesis positioning based on anatomical landmarks and physiological characteristics
• Robotic Arm Guidance: Precise instrument positioning with real-time compensation for patient movement
• Multiple Safety Protections: Integrated safeguards prevent bone cuts outside planned parameters
• Platform Scalability: Modular design supports expansion to additional orthopedic indications

Technical Specifications

With over 1,500 assisted TKA procedures globally, SkyWalker uses CT-based 3D navigation and a self-developed robotic arm for sub-millimeter positioning in knee and hip arthroplasty.

Clinical Applications

SkyWalker has been deployed across orthopedics, joint surgery, and sports medicine departments for:

Total Knee Arthroplasty (TKA): Primary indication with over 1,500 assisted procedures Total Hip Arthroplasty (THA): Expanded indication approved September 2023

Clinical sites have achieved significant procedure volumes, with Gansu Provincial People’s Hospital completing approximately 200 TKA cases and Germany’s Nettetal Municipal Hospital exceeding 200 TKA procedures. The system has demonstrated stable performance across challenging cases including femoral shaft fracture post-intramedullary nail fixation and severe rheumatoid arthritis requiring joint replacement.

Regulatory Status

SkyWalker represents the only Chinese orthopedic robot with concurrent certification across these major regulatory jurisdictions.

Global Commercialization

As of end 2024, SkyWalker achieved cumulative global orders exceeding 40 units, with installations in China, United States, Germany, Italy, Belgium, Greece, Australia, and Brazil. The 2024 annual order volume reached 25 units globally, maintaining leadership among Chinese orthopedic robot manufacturers in international markets.

Overseas commercial deployments in 2024 included 11 units with active clinical use, demonstrating market acceptance in developed markets where SkyWalker competes against established international orthopedic robot platforms.

Associated Products

NaviBot Knee Replacement Surgery Planning Software: Received NMPA approval in April 2023, this companion software enhances preoperative planning capabilities for TKA procedures performed with the SkyWalker system.

Frequently Asked Questions

What joint replacement surgeries can SkyWalker perform?

SkyWalker has NMPA approval for both total knee arthroplasty (TKA) and total hip arthroplasty (THA). The FDA clearance covers TKA.

How does SkyWalker compare to other orthopedic robots?

SkyWalker uses CT-guided navigation with a self-developed robotic arm, providing sub-millimeter positioning accuracy. It is the only Chinese system with concurrent FDA, CE, and NMPA certifications.

Is SkyWalker available in the United States?

Yes, SkyWalker received FDA 510(k) clearance in July 2022 and has commercial installations in the United States as part of MicroPort MedBot’s global commercialization strategy.

What is the difference between SkyWalker and Honghu?

SkyWalker is the international brand name; Honghu (鸿鹄) is the domestic Chinese brand name. They refer to the same orthopedic surgical robot system.