Information
38 Digital-ro 29-gil, Guro District, Seoul, South Korea
+82 2-6902-8401
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Overview
- Summary
- Osteonic Co., Ltd. is a global medical device company specializing in the development and manufacturing of orthopedic and dental implants, offering innovative products in Cranio-Maxillofacial (CMF), Trauma, and Sports Medicine fields. The company produces products based on metal and biodegradable composite materials, expanding its product lines to include Gastrointestinal (GI) Endoscopy Devices and Endoscopic Devices, aiming to transform into a total medical device company. Through continuous investment in research and development, it provides various medical solutions contributing to the improvement of human health. Established in 2012 and listed on KOSDAQ in 2018, the company shows steady growth in both domestic and international markets.Osteonic Co., Ltd. is a global medical device company specializing in the development and manufacturing of orthopedic and dental implants, offering innovative products in Cranio-Maxillofacial (CMF), Trauma, and Sports Medicine fields. The company produces products based on metal and biodegradable composite materials, expanding its product lines to include Gastrointestinal (GI) Endoscopy Devices and Endoscopic Devices, aiming to transform into a total medical device company. Through continuous investment in research and development, it provides various medical solutions contributing to the improvement of human health. Established in 2012 and listed on KOSDAQ in 2018, the company shows steady growth in both domestic and international markets.
- Key Products/Technologies
- CMF System (Optimus): A product line for the treatment and reconstruction of cranio-maxillofacial regions, including Maxillofacial, Mandible, IMF Screw, Neuro Plating System, Customized Mesh, Power Driver, Facial, Orthognathic, Real Fit Custom-made Cranial Implant, and Real Fit Mandible Compression Plate. Used for correcting the skull, fibula, zygomatic bone, and upper and lower jaws, this product line received US FDA approval in 2015.CMF System (Optimus): A product line for the treatment and reconstruction of cranio-maxillofacial regions, including Maxillofacial, Mandible, IMF Screw, Neuro Plating System, Customized Mesh, Power Driver, Facial, Orthognathic, Real Fit Custom-made Cranial Implant, and Real Fit Mandible Compression Plate. Used for correcting the skull, fibula, zygomatic bone, and upper and lower jaws, this product line received US FDA approval in 2015.
- Trauma & Extremities (Signex, Quantum): Products used for body trauma and limb reconstruction, consisting of Hand & Wrist System (Hand Plating System, Distal Radius Plating System, Signex Wrist System, Galaxy Wrist System), Foot System (Foot Plating System), Universal 3.5/5.0 System, Cannulated Screw System, Humerus Compression Plate, Radius Compression Plate, Tibia Compression Plate, Clavicle Compression Plate, and Small Bone Fragment Compression Screw. This product line obtained US FDA approval for 927 trauma products in June 2024.Trauma & Extremities (Signex, Quantum): Products used for body trauma and limb reconstruction, consisting of Hand & Wrist System (Hand Plating System, Distal Radius Plating System, Signex Wrist System, Galaxy Wrist System), Foot System (Foot Plating System), Universal 3.5/5.0 System, Cannulated Screw System, Humerus Compression Plate, Radius Compression Plate, Tibia Compression Plate, Clavicle Compression Plate, and Small Bone Fragment Compression Screw. This product line obtained US FDA approval for 927 trauma products in June 2024.
- Sports Medicine (Kinex): Products used in surgeries to fix ligament tissues to bone when joint ligaments are damaged, including ACL Screw, Fix2Lock Medial Anchor, Fix2Lock Lateral Anchor, suture anchors, and ligament reconstruction implants. These products utilize uniquely developed biodegradable composite materials, offering biocompatibility and optimized physical strength and function. This product line completed US FDA approval for 10 sports medicine products in December 2024.Sports Medicine (Kinex): Products used in surgeries to fix ligament tissues to bone when joint ligaments are damaged, including ACL Screw, Fix2Lock Medial Anchor, Fix2Lock Lateral Anchor, suture anchors, and ligament reconstruction implants. These products utilize uniquely developed biodegradable composite materials, offering biocompatibility and optimized physical strength and function. This product line completed US FDA approval for 10 sports medicine products in December 2024.
- Spine Product Line: Spinal implant products, such as the ASTER-ACP Plate & Screw System, a spinal fixation system used in cervical spine surgeries to ensure stability and aid bone fusion. It includes various spinal implant products like spinal fusion cages and plates, having received US FDA approval in March 2026.Spine Product Line: Spinal implant products, such as the ASTER-ACP Plate & Screw System, a spinal fixation system used in cervical spine surgeries to ensure stability and aid bone fusion. It includes various spinal implant products like spinal fusion cages and plates, having received US FDA approval in March 2026.
- Dental Product Line (Optimus D): Products used in dental surgeries, including Mandible Compression Bone Screw, Palatal Plate Optimus D PalaFix, Torque Dental Screwdriver, and Dental Implant Surgery Instrument Kit. This line includes titanium prosthetic devices for orthodontics, co-developed with Yonsei University.Dental Product Line (Optimus D): Products used in dental surgeries, including Mandible Compression Bone Screw, Palatal Plate Optimus D PalaFix, Torque Dental Screwdriver, and Dental Implant Surgery Instrument Kit. This line includes titanium prosthetic devices for orthodontics, co-developed with Yonsei University.
- Core Technologies: Ultra-precision metal processing technology enables the production of implantable medical devices with precise structures. Biodegradable composite material development and manufacturing technology is a key capability for creating biocompatible products with optimized physical strength and function. Automated system-based high-quality product manufacturing capability ensures efficient and stable product supply.Core Technologies: Ultra-precision metal processing technology enables the production of implantable medical devices with precise structures. Biodegradable composite material development and manufacturing technology is a key capability for creating biocompatible products with optimized physical strength and function. Automated system-based high-quality product manufacturing capability ensures efficient and stable product supply.
- Core Advantages
- Proprietary Biodegradable Composite Material Technology: The company possesses the technology to independently develop and apply biocompatible biodegradable composite materials with optimized physical strength and function. This capability is demonstrated in products like the Kinex Sports Medicine line, offering the significant advantage of not requiring follow-up removal surgeries, a core competitive edge.Proprietary Biodegradable Composite Material Technology: The company possesses the technology to independently develop and apply biocompatible biodegradable composite materials with optimized physical strength and function. This capability is demonstrated in products like the Kinex Sports Medicine line, offering the significant advantage of not requiring follow-up removal surgeries, a core competitive edge.
- Global OEM/ODM Partnerships: Securing stable overseas sales channels through exclusive supply agreements with Zimmer Biomet, the world's second-largest orthopedic medical device company, and B.Braun (Aesculap), a neurosurgery specialist. These partnerships are crucial for gaining international recognition for its technology and product competitiveness.Global OEM/ODM Partnerships: Securing stable overseas sales channels through exclusive supply agreements with Zimmer Biomet, the world's second-largest orthopedic medical device company, and B.Braun (Aesculap), a neurosurgery specialist. These partnerships are crucial for gaining international recognition for its technology and product competitiveness.
- Extensive Product Portfolio and Expansion Strategy: Holding a broad range of products in various orthopedic and medical device fields, including CMF, Trauma, Sports Medicine, Spine, and Dental. The company also pursues continuous product expansion into new lines such as GI Endoscopy Devices and Endoscopic Devices through aggressive R&D investments, a growth strategy aimed at becoming a total medical device company.Extensive Product Portfolio and Expansion Strategy: Holding a broad range of products in various orthopedic and medical device fields, including CMF, Trauma, Sports Medicine, Spine, and Dental. The company also pursues continuous product expansion into new lines such as GI Endoscopy Devices and Endoscopic Devices through aggressive R&D investments, a growth strategy aimed at becoming a total medical device company.
- Global Market Certifications and Sales Network: Obtaining essential certifications for major overseas market entry, including US FDA approvals (CMF, Trauma, Sports Medicine, Spine product lines), Medical Device Single Audit Program (MDSAP) certification (for 4 countries: USA, Canada, Australia, Brazil, Japan), European CE certification, and Korean Ministry of Food and Drug Safety approval. The establishment of an extensive global sales network through 83 distributors in 58 countries is also a significant competitive advantage.Global Market Certifications and Sales Network: Obtaining essential certifications for major overseas market entry, including US FDA approvals (CMF, Trauma, Sports Medicine, Spine product lines), Medical Device Single Audit Program (MDSAP) certification (for 4 countries: USA, Canada, Australia, Brazil, Japan), European CE certification, and Korean Ministry of Food and Drug Safety approval. The establishment of an extensive global sales network through 83 distributors in 58 countries is also a significant competitive advantage.
- Ultra-precision Processing and Manufacturing Capabilities: Possessing ultra-precision metal processing technology optimized for producing implantable medical devices with intricate structures. This enables the creation of high-performance products that meet the demands of surgeons and clinical requirements during surgery, further supported by automated system-based high-quality product manufacturing capabilities.Ultra-precision Processing and Manufacturing Capabilities: Possessing ultra-precision metal processing technology optimized for producing implantable medical devices with intricate structures. This enables the creation of high-performance products that meet the demands of surgeons and clinical requirements during surgery, further supported by automated system-based high-quality product manufacturing capabilities.
- Target Industries
- Medical Device IndustryMedical Device Industry
- OrthopedicsOrthopedics
- NeurosurgeryNeurosurgery
- Plastic Surgery and Oral & Maxillofacial Surgery (CMF Surgery)Plastic Surgery and Oral & Maxillofacial Surgery (CMF Surgery)
- DentistryDentistry
- Sports MedicineSports Medicine
- Major Markets
- Egypt, Morocco, Sudan, Lebanon, South AfricaEgypt, Morocco, Sudan, Lebanon, South Africa
- Japan, India, China, Vietnam, Pakistan, Indonesia, Thailand, Sri Lanka, Hong Kong, Mongolia, Malaysia, Taiwan, Philippines, Saudi Arabia, United Arab EmiratesJapan, India, China, Vietnam, Pakistan, Indonesia, Thailand, Sri Lanka, Hong Kong, Mongolia, Malaysia, Taiwan, Philippines, Saudi Arabia, United Arab Emirates
- Germany, Bulgaria, Spain, Lithuania, Russia, Italy, Albania, GreeceGermany, Bulgaria, Spain, Lithuania, Russia, Italy, Albania, Greece
- United States, MexicoUnited States, Mexico
- AustraliaAustralia
- Argentina, Chile, Brazil, Colombia, Guatemala, Ecuador, Peru, Dominican RepublicArgentina, Chile, Brazil, Colombia, Guatemala, Ecuador, Peru, Dominican Republic
- Certifications/Patents
- US FDA Approval: Obtained US Food and Drug Administration (FDA) approvals for key product lines, including CMF products (2015), 927 Trauma products (June 2024), 10 Sports Medicine products (December 2024), and Spine implant products (ASTER-ACP Plate & Screw System, March 2026).US FDA Approval: Obtained US Food and Drug Administration (FDA) approvals for key product lines, including CMF products (2015), 927 Trauma products (June 2024), 10 Sports Medicine products (December 2024), and Spine implant products (ASTER-ACP Plate & Screw System, March 2026).
- Medical Device Single Audit Program (MDSAP) Certification: Acquired MDSAP certification in February 2024, jointly operated by the United States, Canada, Australia, Brazil, and Japan. This certification provides full or partial exemption from medical device certification reviews in these five countries.Medical Device Single Audit Program (MDSAP) Certification: Acquired MDSAP certification in February 2024, jointly operated by the United States, Canada, Australia, Brazil, and Japan. This certification provides full or partial exemption from medical device certification reviews in these five countries.
- European CE Certification: Obtained European CE certification for most of its product lines.European CE Certification: Obtained European CE certification for most of its product lines.
- Korean Ministry of Food and Drug Safety (MFDS) Approval: Received MFDS approval for domestic market sales, including its independently developed spinal implant product line (May 2023).Korean Ministry of Food and Drug Safety (MFDS) Approval: Received MFDS approval for domestic market sales, including its independently developed spinal implant product line (May 2023).
- Patents: Patent application related to an "Anchor delivery apparatus."Patents: Patent application related to an "Anchor delivery apparatus."
Introduction
Location
38 Digital-ro 29-gil, Guro District, Seoul, South Korea
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