China Orthopedic Innovative Devices Report 2023: IPO Filing Highlights Eight NMPA-Approved Breakthroughs

Dec 26, 2023 16:30 CST Updated 16:30

Ubiosis

Medical Device Manufacturer

MicroPort

Medical Device Manufacturing Enterprise

TINAVI

Orthopedic Surgical Robot Developer

Longwood Valley

Developer of Orthopedic Artificial Intelligence and Surgical Robot Solutions

Rossum Robot

Intelligent Orthopedic Surgical Robot System Developer

Source: Bone Future; Editor: Zheng Siyu

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As of December 20, 2023,The official website of the National Medical Products Administration (NMPA) announced eight innovative orthopedic medical devices.From Ubiosis, MicroPort OrthoReconDepartment, TINAVI, etc.,Overall hasThree Major Trends Emerge：

Personalization:With the development of additive manufacturing technology, orthopedic implants are increasingly able to be personalized designed and manufactured according to the specific conditions of patients, improving the matching and comfort of the implants.

Biologization:BiologicalMaterialMaterialTechSurgery's MoreNewIterationOn behalf ofDown，OrthopedicsPlantImplants can better simulate the biological properties of the human body and improve the biocompatibility of the implants., meanwhileReduceGrindDamage, Reduce Revision Rate。

Intelligentization:Orthopedic surgical robots can assist doctors more automatically in surgical planning, simulation, and operation, improving the accuracy and efficiency of surgeries.SurgeryRisk Reduction，Reduced Postoperative Complications。

Bone Future took stock of these products.Attached are relevant reports (sorted by approval time) for readers' reference only.

The eight orthopedic innovative medical devices approved in 2023 can be mainly divided into two categories:

Orthopedic Implants:

IncludingCollagen Cartilage Repair Scaffold、Zirconium Niobium Alloy Femoral Head、Additively Manufactured Polyether Ether Ketone (PEEK) Cranial Defect Repair Implant、Additively Manufactured Customized Artificial Knee Joint ProsthesisMainly used to replace or repair damaged bones or joints. The technology development trend is to adopt more biomaterials, personalized design, and additive manufacturing technology to improve the biocompatibility, mechanical properties, and matching of implants.

Orthopedic Surgery Robot:

IncludingKnee Joint Replacement Surgery Navigation and Positioning System、Hip Joint Replacement Surgery Navigation and Positioning System、Joint Replacement SurgerySimulation Software,Pelvic Fracture Reduction Surgical Navigation and Positioning SystemMainly used to assist doctors in orthopedic surgeries, improving the accuracy and efficiency of surgical positioning, and reducing surgical risks and complications. The technological development trend is to adopt more artificial intelligence, robotics, and imaging technologies to enhance the intelligence, automation, and minimally invasive level of navigation and positioning systems.

1. Ubiosis: Collagen Cartilage Repair Scaffold

Product Overview:

Product Name: Collagen Cartilage Repair Scaffold

Manufacturer: Ubiosis Co., Ltd. (Youbai'aosi), South Korea

Approval Date: 2023/4/4

Registration Certificate for Imported Medical Devices: 20233130129

The product innovatively adopts a bacteria-removal process during collagen extraction in production and removes the immunogenic telopeptide structure, enabling the mass and stable production of collagen material with a complete triple-helix structure.

The product uses collagen as its main component, serving as a biological scaffold to provide space for the adhesion, proliferation, and migration of autologous bone marrow mesenchymal stem cells (BMSCs). After the collagen cartilage repair scaffold is implanted, chondrocytes are derived from the differentiation of BMSCs and the migration and proliferation of surrounding healthy cartilage tissue. Chondrocytes continuously synthesize and secrete type II collagen, forming new cartilage tissue to repair defective cartilage. During this process, the collagen scaffold gradually degrades, and the degradation products can be absorbed by chondrocytes as nutrients or excreted through metabolism.

Existing cartilage injury repair technologies commonly include microfracture, cartilage transplantation, chondrocyte transplantation, and joint replacement, among others. The collagen cartilage repair scaffold, used in conjunction with knee microfracture surgery, is expected to benefit more patients upon its market release.

Company Introduction:

Ubiosis is a medical device manufacturer located in South Korea, dedicated toCOLTRIX, a medical collagen protein implantable in living organisms, and Hemovister, a medical device for blood viscosity measurementProduction and sales.

Latest! Three Innovative Medical Devices Approved for Marketing

2. MicroPort: Zirconium Niobium Alloy Femoral Head

Product Overview:

Product Name: Zirconium Niobium Alloy Femoral Head

Manufacturer: Suzhou MicroPort OrthoRecon Co. LTD

Approval Date: 2023/6/15

National Medical Device Registration: 20233130813

Zirconium-Niobium Alloy Femoral Heads are used in conjunction with other hip prosthesis components from the same series by the company, suitable for total hip arthroplasty. The product is made of zirconium-niobium alloy compliant with international standards (ASTM F2384) and features a ceramic-like layer formed through surface gradient oxidation, which reduces wear on highly cross-linked polyethylene acetabular liners and lowers the revision rate of hip prostheses.

Compared with cobalt-chromium alloy femoral head products of similar intended use commonly used in clinical practice, this product can reduce metal ion release and lower articular surface wear; compared with ceramic femoral head products, it can reduce the risks of prosthesis fracture and joint noise. The market launch of this product will provide more options for clinical treatment.

Company Introduction:

MicroPort® Orthopedics Group, one of the subsidiaries of MicroPort Medical Science and Technology Co., Ltd. (00853.HK), started in 2009. After more than a decade of independent research and development and efficient integration of global resources and markets, it has achieved global operation of its orthopedic business, becomingOne of the largest orthopedic companies in China currently`, Company`Orthopedic Product Layout: Four Major Segments - Hip Joint, Knee Joint, Spine, and TraumaIts products are marketed in more than 60 countries and regions, with offices in major cities around the world. The MicroPort Orthopedics China headquarters in Suzhou is an innovative orthopedic industrial park that integrates R&D, manufacturing, logistics, academia, and other functions.

Just Now! Innovative Product of MicroPort Subsidiary Approved

3. TINAVI: Knee Replacement Surgery Navigation and Positioning System

Product Overview:

Product Name: Knee Arthroplasty Surgical Navigation and Positioning System

Manufacturer: TINAVI Medical Technologies Co., Ltd.

Approval Date: 2023/7/13

National Medical Device Registration: 20233010962

This product, composed of a main unit, a main control console cart, and a navigation positioning toolkit, utilizes a six-degree-of-freedom robotic arm to assist doctors in performing tasks such as the installation of knee joint prostheses during adult total knee replacement surgeries, and is a first-of-its-kind innovation in China. Compared with traditional manual total knee replacement surgery, this product ensures surgical positioning accuracy, reduces the probability of adverse events and complications, and minimizes X-ray radiation exposure for both doctors and patients.

Company Introduction:

TINAVI was founded in 2005 and is a company dedicated to...Orthopedic surgical robots and their related technologies integrate independent innovation, scaled production, professional marketing, and high-quality clinical application.A high-tech enterprise, and also the first in China and the fifth globally to obtain a medical robot registration license.

TINAVI's core product — the TiRobot orthopedic surgery robot — is used to assist doctors in precisely positioning implants or surgical instruments. It can be widely applied in spinal and trauma orthopedic surgeries, with clinical accuracy reaching within 1mm. This significantly reduces intraoperative radiation and improves surgical efficiency. By the end of the fourth quarter of 2023, the clinical application of the TiRobot series orthopedic robots had covered more than 180 medical institutions across 30 provinces, autonomous regions, and municipalities in China, with over 50,000 surgeries performed.

Approved for Marketing! Knee Arthroplasty Surgical Navigation and Positioning System

4. Lancet Robot: Hip Arthroplasty Navigation and Positioning System

Product Overview:

Product Name: Hip Joint Replacement Surgery Navigation and Positioning System

Manufacturer: Hangzhou Lancet Robot Co., Ltd.

Approval Date: 2023/8/10

National Medical Device Registration Certificate: 20233011155

This product consists of a robotic arm cart, a main control console cart, an optical tracking cart, a foot pedal switch, a medical electric bone drill, and surgical instruments. When used in conjunction with verified hip prostheses and surgical tools, it assists doctors in performing tasks such as acetabular grinding, femoral osteotomy, and hip prosthesis implantation during hip replacement surgeries. The product has independent intellectual property rights, and its performance indicators meet the standards of international devices of the same type.

Compared with traditional artificial hip replacement surgery, this product can improve the accuracy of surgical positioning, reduce the probability of adverse events and complications, and decrease X-ray radiation damage to both doctors and patients.

Company Introduction:

Hangzhou Lancet Robot Co., Ltd. was founded in 2018.It is the only medical robotics innovation company in the world that has deeply invested in the four golden surgical tracks of hip replacement, knee replacement, dental implantation, and vascular intervention.The R&D team boasts top-tier medical expertise and robust technical capabilities, maintaining an internationally advanced level in key robot technologies such as precision, intelligence, and safety algorithms. They can provide hospitals with comprehensive solutions covering the entire process, including AI-assisted diagnosis, personalized surgical planning, surgical navigation robotic systems, and postoperative evaluation. Additionally, they have established an integrated innovation platform for industry, academia, research, and medicine with the Affiliated Drum Tower Hospital of Nanjing University Medical School.

Navigation and Positioning System for Hip Replacement Surgery Approved for Marketing!

5. Longwood Valley: Joint Replacement Surgery Simulation Software

Product Overview:

Product Name: Joint Replacement Surgery Simulation Software

Manufacturer: Longwood Valley MedTech

Approval Date: 2023/10/23

China Medical Device Registration: 20233211543

The product consists of a scanning installer and an authorization file. The software includes six functional modules: User Management Module, 3D Reconstruction Imaging Module, Deep Learning-based Bone Segmentation Module, Bone Marrow Cavity Centerline Extraction Module, Deep Learning-based Recognition and Measurement Module, and Prosthesis Template Matching Module.

This product adopts China's first deep learning technology to perform 3D reconstruction and segmentation of CT images in the required format, automatically identify anatomical landmarks, and assist doctors in simulating adult hip joint and total knee replacement surgeries. The anticipated market launch of this product is expected to improve the precision of artificial joint placement and reduce postoperative complications.

Company Introduction:

Longwood Valley is a company focused onOrthopedic Artificial Intelligence and Surgical Robot SolutionsNational High-tech Enterprise, National Specialized and Innovative“Little Giant”Enterprises provide a full-process solution for hospital orthopedics, including artificial intelligence-assisted diagnosis, personalized surgical three-dimensional medical image reconstruction, surgical robots, postoperative evaluation, and more.

China's First AI+ Orthopedic Treatment Innovative Medical Device Class III Registration Certificate Approved for Marketing by NMPA, Longwood Valley MedTech Pioneers AI-Assisted Orthopedic Surgical Treatment, Bringing Technology to Benefit the People

Intelligent Matching of Joint Prostheses, Deeply Reaching Grassroots Hospitals: Longwood Valley MedTech Promotes Digital Upgrade of Orthopedic Diagnosis and Treatment with Artificial Intelligence

6. Kangtuo Medical: Additively Manufactured Polyether Ether Ketone (PEEK) Cranial Defect Repair Implant

Product Overview:

Product Name: Additively Manufactured Polyether Ether Ketone (PEEK) Cranial Defect Repair Implant

Manufacturer: Xi'an Kangtuo Medical Technology Co., Ltd.

Approval Date: 2023/11/9

National Medical Device Registration Certificate: 20233131652

This product is based on the radiological data of patients with skull defects and innovatively uses medical-grade polyetheretherketone (PEEK) powder. It is manufactured through selective laser sintering additive manufacturing, allowing it to match the patient's defect area. The three-dimensional embedding method achieves skull defect replacement, restoring the original curvature of the patient’s skull and realizing three-dimensional reconstruction of the defect area.

This product is suitable for surgical treatment in the repair and reconstruction of skull defects. It utilizes additive manufacturing technology to print more complex craniofacial bone structures, while the printed texture of the skull defect repair prosthesis has no mechanical cutting effect on the scalp and poses no risk of prosthesis extrusion. In addition, the product addresses the recycling issue of polyetheretherketone (PEEK) powder in selective laser sintering, improving material utilization and reducing production costs while maintaining equivalent clinical outcomes. The product’s market launch will provide new treatment options for patients.

Company Introduction:

Kangtuo Medical, established in 2005, is a company focused onResearch, Production, and Sales of Class III Implantable Medical DevicesA high-tech enterprise whose main products are applied in the fields of neurosurgical skull repair and fixation, dental implantation, and sternal fixation in thoracic surgery. As of June 2023, the company holds 13 Class III implantable medical device registration certificates. The company was listed on the STAR Market in 2021.

Xi'an Kangtuo Medical Technology Co., Ltd. has pioneered several products in niche fields, with a key focus on the development of PEEK material products. In 2015, the company obtained the first PEEK bone plate registration certificate for a product manufactured in China.

From 2018 to 2020, the compound annual growth rate of PEEK (polyetheretherketone) material cranial repair and fixation products reached 53.70%, capturing the largest market share in this field in China. The company is also one of the few domestic enterprises able to provide diversified solutions for neurosurgical cranial repair and fixation based on patient needs.

Another Innovative Medical Device Approved for Marketing! 3D-Printed PEEK Skull Prosthesis

7. Naton Biotechnology (Beijing) Co., Ltd.: Additively Manufactured Customized Artificial Knee Joint Prosthesis

Product Overview:

Manufacturer: Naton Biotechnology (Beijing) Co., Ltd.

Approval Date: 2023/11/17

National Medical Device Registration: 20233131698

This product includes femoral condyle prostheses, tibial tray prostheses, and meniscus prostheses. The femoral condyle and tibial tray prostheses are manufactured through laser additive manufacturing using cobalt-chromium-molybdenum powder, while the meniscus prosthesis is made from ultra-high molecular weight polyethylene material. The product features a personalized design for total knee replacement, with its biomimetic articular surface design capable of reconstructing normal femoropatellar joint movement function.

This product is used in conjunction with bone cement and is suitable for knee joint prosthesis replacement. It can be used by patients with osteoarthritis as well as special patients. The product achieves good coverage on all osteotomy surfaces, effectively addressing issues of mismatch and over-coverage. Its market release will provide new treatment options for patients.

Company Introduction:

Beijing Naton Technology Group is an international medical health industry group that integrates independent innovation research and development, large-scale production, professional marketing, and high-quality medical service applications. The core businesses under Naton involveMedical Implants, Smart Surgical Devices, Bio-based Materials, Epidemic Prevention Supplies...and other fields, with 11 national high-tech enterprises under its umbrella.

Naton Biotechnology (Beijing) Co., Ltd., a subsidiary of NatonAs a "Specialized, Precise, Unique, and Innovative" small and medium-sized enterprise in Beijing, Naton Biotechnology (Beijing) Co., Ltd. is committed to the research, innovation, and quality enhancement of a full range of sports medicine products. Building on the group's strong R&D and intellectual resources, the company’s biotech R&D and technical teams deeply integrate medical and engineering technologies to develop and innovate medical devices. They have successively collaborated with renowned hospitals and doctors, such as Peking University Third Hospital, 301 Hospital, and Shanghai Sixth Hospital, on product transformation projects.Products involve medical implants, surgical tools, disposable surgical consumables, etc.。

Innovative Device! 3D-Printed Artificial Knee Joint Prosthesis Approved for Market Launch

8. Rossum Robot: Pelvic Fracture Reduction Surgical Navigation and Positioning System

Product Overview:

Product Name: Pelvic Fracture Reduction Surgical Navigation and Positioning System

Manufacturer: Beijing Rossum Robot Technology Co., Ltd.

Approval Date: 2023/12/8

National Medical Device Registration: 20233011923

This product consists of a main control console, a robotic arm console, and navigation positioning tools. It is used for fracture reduction in adult pelvic fracture surgeries and provides navigation and positioning for surgical tools, bone pins, and screw implants during the procedure. Based on technologies such as preoperative CT and intraoperative CBCT image registration, mirror and curved surface continuity constraints, and force-position dual feedback control, the product enables real-time 3D navigation of bone fragments and tools during surgery, offers planning suggestions for closed pelvic fracture reduction, and controls robotic reduction operations.

This product is China's first surgical navigation and positioning system that uses robotic technology to achieve closed reduction of pelvic fractures. Compared with traditional surgery, it can improve the success rate of closed reduction, reduce the risks of open surgery, shorten recovery and hospitalization time, and decrease radiation exposure for both patients and medical staff.

Company Introduction:

Beijing Rossum Robot Technology Co., Ltd. was established in September 2017 and is committed to the technological innovation of medical robotics.Starting from the treatment of pelvic fractures, which has the greatest difficulty in orthopedic surgery and the strongest clinical demand, using digital and intelligent means to "replicate" the experience of clinical experts, developing world-leading intelligent orthopedic surgical robots, and promoting orthopedic surgeries towards intelligence, minimally invasive procedures, and standardization.

Another Innovative Device Approved! World's First Pelvic Reduction Orthopedic Surgical Robot

International Orthopedic Enterprises:

Stryker｜Johnson & Johnson

Zimmer Biomet ｜Medtronic

Smith+Nephew｜Enovis ｜NuVasive

Globus Medical｜Orthofix｜CONMED

Chinese Orthopedic Enterprises:

Chunli Medical｜Sanyou Medical ｜WEGO Orthopaedics ｜Dabo Medical

Kailite Medical｜OsteoMed ｜Haohai BioScience ｜AK Medical