A-Kang Medical's Magnetically Controlled Non-Invasive Extendable Prosthesis System Enters NMPA Innovative Medical Device Review Pathway

May 12, 2025 17:01 CST Updated 17:01

AK Medical

Medical Device R&D Manufacturer

Source: Bone Future

Reprint Requirements: You can directly repost, but please credit the source at the beginning of the article.

On March 26, 2025, the NMPA announced the public notice of the review results for the special review application of innovative medical devices (No. 3 of 2025), with 14 products entering the innovation channel. Among them is the application from AK Medical Holdings Limited.Magnetic Control Non-invasive Extendable Prosthesis System。

In the treatment of spinal tumors or other complex lesions, patients often require multi-level vertebral resection. Traditional fixed-length prostheses struggle to meet long-term postoperative rehabilitation needs, andHigh Risk of Secondary Surgery ExtensionAK Medical has developed a magnetically controlled non-invasive extendable prosthesis system by leveraging its advantages in 3D printing and additive manufacturing technology.

# Magnetically Controlled Non-Invasive Extendable Prosthesis System

AK MedicalThe magnetically controlled non-invasive extendable prosthesis system developed is a medical device used for orthopedic repair, which utilizes magnetic control technology to achieve non-invasive extension of the prosthesis. This technologyAvoids the need for a second surgery during the traditional prosthesis lengthening process., reducing the patients' suffering and surgical risks.

Basic Principles：

Such systems typically utilizeMagnetic memory alloy or magnetic drive technologyTo achieve the extension of the prosthesis. Magnetically shape-memory alloys can deform under the influence of an external magnetic field, thereby driving the movement of the extension components of the prosthesis.

Components：

First Prosthesis: Generally includes a lower sleeve and a transmission component, with the transmission component being rotatably mounted inside the lower sleeve.
Second Prosthesis: Including an intramedullary rod and a screw connected to it, with the screw passing through the transmission component.
Deformation Structure: Made of magnetic memory alloy, set inside the lower sleeve, and cooperating with the transmission component. It is driven by an external magnetic field to rotate the transmission component, thereby extending the prosthesis.

Technical Features

Magnetic Control Technology: The prosthesis can be extended through an external magnetic field without surgical intervention.
3D Printing Customization: Using 3D printing technology to customize prostheses according to the specific bone structure of patients, improving the fit and stability of the prostheses.
Biocompatibility: The prosthetic material has good biocompatibility, which can reduce postoperative infection and rejection reactions.

Magnetically Controlled Non-invasive Extendable Prosthesis SystemEnter the innovation channel,Broke the Import Monopoly. The product has passed the special review of the National Medical Products Administration (NMPA) and received priority evaluation and resource support.

# Company Introduction

AK Medical Holdings LimitedFounded in 2003, it isCore Subsidiary of AK MedicalAK Medical possesses postdoctoral research workstations, Beijing Enterprise Technology Centers, Beijing Engineering and Technology Research Centers, Beijing-level corporate scientific research and development institutions, and is recognized as a benchmark enterprise for intelligent manufacturing in Beijing (digital workshop). It also has national and provincial-level scientific innovation platforms and a CNAS-accredited testing center.

Main Business

Artificial Joint Implants: Covering the full range of products including primary hip and knee replacements, severe deformities, complex conditions, and revision surgeries.
Auxiliary Devices: Provide supporting instruments for orthopedic surgery.
3D Printing Technology: Development of 3D-printed metal implants, including hip joints, knee joints, spinal interbody fusion devices, and artificial vertebral bodies, etc.
Personalized Solutions: Utilizing 3D printing technology to provide personalized medical solutions, meeting the special needs of different patients.

Development History

2015: The 3D ACT Artificial Hip Joint System has been approved for marketing, becomingThe First in China3D Printed Implant Products.
2018: The A3 Knee System Receives FDA Clearance, BecomingThe First in Mainland ChinaProstheses with this certification.
2023: Metal 3D-printed tibial plateau system and metal additive-manufactured thoracolumbar fusion matched prosthesis system successivelyApproved for Marketing。
Overseas Expansion: Through AcquisitionJRI UK and Medtronic's Libel, further expand the overseas market.