WJ SUPERLIG® Reinforced Coated Artificial Ligament – China's First Innovative Medical Device in Sports Medicine Receives NMPA Approval

Apr 21, 2025 21:50 CST Updated 21:50

Wanjie Medical

Orthopedic Consumables Manufacturer

Source: Bone Future

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On April 9, 2025, the National Medical Products Administration approvedBeijing Wanjie Medical Device Co., LtdThe"Artificial Ligament"(In China Medical Device Registration No. 20253130733) Innovative Product Registration Application.

The product adoptsSurface Modification Technology, the hydrophilic coating of polystyrene sulfonate sodium is grafted onto the part of the artificial ligament that contacts the soft tissue, and a hydroxyapatite coating is applied through a mineralization process on the part that contacts the bone tunnel, providing excellent fixation after implantation. The product is used in conjunction with the company'sNon-Absorbable Ligament Fixation Screw, applicable for compensating or enhancing the damagedKnee Cruciate Ligament。

# Research and Development Background

Knee Joint Cruciate Ligament InjuryIt is one of the common sports injuries. Traditional treatment methods include autologous or allogeneic ligament transplantation, but there are problems such as limited donors, complex surgery, and long postoperative recovery time. Therefore, developing an artificial ligament product that can replace or enhance the function of the damaged cruciate ligament has important clinical significance.

In recent years, with the development of biomaterials science and tissue engineering technology, the research on artificial ligaments has gradually become a hotspot. The ideal ligament substitute should possessGood biocompatibility, biomechanical properties, and the ability to promote tissue repair。

The Development Process and Main Types of Artificial Ligaments

At the beginning of the 21st century, artificial ligaments mainly experienced the following innovations and applications:

In 2014, Lubowitz et al. proposed "Internal Brace"Concept, which involves the use of artificial materials to enhance structural strength in ligament soft tissue repair."
In June 2020, Miach Orthopaedics launched a resorbable anterior cruciate ligament repair product through the De Novo pathway.BEAR^® Implant, for tissue-engineered artificial ligaments.
April 2021,BioBrace^®Company Artificial LigamentIt is a bio-composite induced scaffold, featuring a highly porous collagen matrix reinforced structurally with bioresorbable microfilaments.
February 7, 2022Wanjie Medical Artificial LigamentEntry into the NMPA Special Review Application Results for Innovative Medical Devices Public Disclosure.
On May 14, 2023, the collaboration between Liget and Professor Chen Shiyi from Huashan resulted in the development ofThe First Ligament Produced in ChinaOfficially launched.
On April 9, 2025, Beijing Wanjie Medical Device Co., Ltd.'s "Artificial Ligament"([China Medical Device Registration No. 20253130733]) Approved for Marketing."

Currently, the main types of artificial ligaments on the market include:

LARS Ligament: Woven from polyethylene terephthalate (PET) biomimetic material. Designed with separated knees, divided into the bone canal section and the central section; the bone canal section is woven, while the central section consists of longitudinally running free fibers pre-twisted by 90°. HasExcellent biomechanical properties and biocompatibility, with high strength but poor viscoelasticity. Reconstruction surgery does not necessarily need to meet the "isometric" or "quasi-isometric" principle, and the surgical requirements are high.
BEAR^® Implant: Composed of bovine extracellular matrix collagen. Suitable for skeletally mature patients aged at least 14 years with MRI-confirmed complete ACL rupture, and there must be an ACL stump that can be connected to the tibia for repair. During the surgery, 10ml of autologous blood is drawn. BEAR^®The implant stabilizes the autologous blood in the gap at both ends of the torn ligament, forming fibrovascular tissue after about 8 weeks.
BioBrace^™Artificial Ligament: A highly porous collagen matrix reinforced structurally with bioresorbable microfilaments. The absorbable PLLA microfilaments provide temporary mechanical support throughout the healing process, while its collagen biomatrix acts as a scaffold to support tissue regeneration. This artificial ligament can provide support before being naturally absorbed.About 2 yearsSupplement Intensity.
FlexBand^®Product Series: Composed of polycaprolactone and polyurethane urea. The fibers are woven into a Dynamic Matrix.^®, its pore size is specifically designed for connective tissue cells and can be used to reinforce the extracapsular ligaments of the medial, lateral, and ulnar collateral ligaments, spring ligament, deltoid ligament, as well as the ankle, knee, and other joints around the body.
Internal Brace（FiberTape）: High-strength suture material made from ultra-high molecular weight polyethylene and polyester. Used as an internal scaffold for ACL/MCL augmentation and repair, providing immediate high-strength mechanical fixation.

# About WJ SUPERLIG^®Artificial Ligament

According to the official information from Wanjie Medical, the company has launchedThe World's FirstWJ SUPERLIG^®Stent-Reinforced Coated Artificial Ligament, the product has been approved by the National Medical Products AdministrationSpecial Approval for Innovative Medical Devices by the Bureau, Becoming a Leader in the Field of Sports MedicineThe First to Obtain This CertificationProduct.

Technical Principle

This artificial ligament adopts surface modification technology, grafting a hydrophilic coating of sodium polystyrene sulfonate on the part that contacts soft tissue to improve the ligament's biocompatibility and tissue integration ability; a hydroxyapatite coating is applied through a mineralization process on the part that contacts the bone tunnel to enhance the ligament's bonding strength with bone tissue.

Material Selection and Structural Design: The artificial ligament is made of polyethylene terephthalate (PET) yarn, with a free fiber section in the middle and a crosswise woven section at both ends. This design ensures the mechanical properties of the ligament and is beneficial for postoperative tissue repair.

Optimization of Biomechanical Performance: By optimizing the weaving process and material properties, the artificial ligament can better simulate the characteristics of natural ligaments in terms of mechanical performance, including indicators such as tensile strength, elongation at break, and residual elongation.

Product Features

Excellent Mechanical Properties：WJ SUPERLIG^®The artificial ligament adopts a high-toughness polyester fiber (PET) body, combined with exclusive surface modification technology, significantly enhancing fatigue resistance and mechanical stability to meet the demands of high-intensity运动, ensuring stable performance over long-term use.

Mineral Coating Technology: Mineralized coating makesContact Force Between Ligament and Bone ScrewSignificantly Enhanced, Fixed IntensityIncrease by 150%, effectively reducing the risk of postoperative loosening;Coating Continuous ReleaseCalcium and Phosphate Ions, activate osteoblast activity, accelerate bone ingrowth, and achieve biological integration of ligaments and bones.
Hydrophilic Coating Design: Hydrophilic coating is effectiveReduce Interfiber Friction, solving the problem of traditional artificial ligament shedding, extending product service life. Hydrophilic environmentContributes to cell adhesion and tissue proliferationClinical data shows a significant increase in tendon encapsulation rate, reducing rejection reactions.

Clinical Research

WJ SUPERLIG^®Artificial ligaments have beenMultiple top-tier tertiary hospitalsComplete clinical trials, the first batch of indications includeAnterior and Posterior Cruciate Ligament Reconstruction, Knee Collateral Ligament ReconstructionHigh-difficulty surgeries. In the future, the product will gradually expand to repair areas such as acromioclavicular ligaments and foot and ankle ligaments, benefiting more patients.

During the preclinical development stage, the artificial ligament underwent multiple experiments, including structural and compositional analysis, product indications, mechanism of action, performance studies, biocompatibility studies, sterilization studies, product shelf-life and packaging studies, as well as animal studies. Animal experimental studies showed that, compared with similar products already on the market, the efficacy and safety indicators of the experimental group were non-inferior to those of the control group.The tensile strength of the experimental group was significantly greater than that of the control group.。

# About Wanjie Medical

Beijing Wanjie Medical Device Co., LtdIt is a high-tech enterprise focusing on minimally invasive orthopedics (sports medicine and spinal minimally invasive) and tissue regeneration. The company emphasizes innovation in research and development, possesses an advanced production system, and continuously launches leading medical consumables, equipment, and tools.

Wanjie MedicalFocused on minimally invasive orthopedics (sports medicine, minimally invasive spine, joint surgery), tissue repair and regeneration, and medical aesthetics. The company's product line includes 4K medical endoscopic camera systems, arthroscopes, percutaneous endoscopes, plasma surgical equipment, medical pulse lavage drainage systems, and more. The company currently ownsTwo products certified by the National Medical Products AdministrationInnovative Medical Device ——"Artificial Ligament", "Articular Cartilage Repair Scaffold"。

As of February 2025, Wanjie Medical has cumulatively applied for various patents.More than 60 items, has been obtained46 SheetsMedical Device Registration Certificate; its core products have achieved full coverage in all 32 provinces, with a coverage rate in tertiary hospitals.Over 80%。

February 2025,Wanjie MedicalAnnounced Successful CompletionNearly 100 Million Yuan in Series B FinancingThis round of financing was invested by a fund under Guoke Investment, with MaiLin Capital serving as the exclusive financial advisor. The funds raised will be mainly used for research and development in the fields of orthopedic minimally invasive and tissue regeneration, accelerating product commercialization, and the iteration of mature products.