Information
38 Digital-ro 29-gil, Guro District, Seoul, South Korea
+82 2-6902-8401
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Overview
- Summary
- Osteonic is a global medical device company specializing in the development and manufacturing of orthopedic implants for CMF, Trauma, and Sports Medicine. The company leverages its proprietary biodegradable composite materials and ultra-precision metal processing technology to offer innovative medical solutions. Osteonic is expanding its product portfolio to include GI Endoscopy Devices, Endoscopic Devices, and spinal implants, transitioning into a total medical device company. With over 70 domestic and international distributors, the company actively expands its global market presence through partnerships with major global players. Continuous R&D investment and securing US FDA approvals for key product lines are central to enhancing its global competitiveness.Osteonic is a global medical device company specializing in the development and manufacturing of orthopedic implants for CMF, Trauma, and Sports Medicine. The company leverages its proprietary biodegradable composite materials and ultra-precision metal processing technology to offer innovative medical solutions. Osteonic is expanding its product portfolio to include GI Endoscopy Devices, Endoscopic Devices, and spinal implants, transitioning into a total medical device company. With over 70 domestic and international distributors, the company actively expands its global market presence through partnerships with major global players. Continuous R&D investment and securing US FDA approvals for key product lines are central to enhancing its global competitiveness.
- Key Products/Technologies
- **CMF System (Cranio-Maxillo-Facial System)**: Implants for craniomaxillofacial surgery, including Optimus CMF System, Maxillofacial, Mandible, and IMF Screw systems. Composed of four individual systems: Optimus Neuro, Optimus Facial, Optimus Orthognathic, and Optimus Mandible, providing solutions for diverse clinical needs. This product line received US FDA approval in 2015, featuring both the Optimus CMF System and the biodegradable CMF Biosorb system.**CMF System (Cranio-Maxillo-Facial System)**: Implants for craniomaxillofacial surgery, including Optimus CMF System, Maxillofacial, Mandible, and IMF Screw systems. Composed of four individual systems: Optimus Neuro, Optimus Facial, Optimus Orthognathic, and Optimus Mandible, providing solutions for diverse clinical needs. This product line received US FDA approval in 2015, featuring both the Optimus CMF System and the biodegradable CMF Biosorb system.
- **Trauma & Extremities System**: Implant product lines such as Signex Trauma System and Quantum Plating System, used for trauma and extremity reconstruction. Primarily titanium-based metal implants for hand, foot, arm, and leg fractures and trauma reconstruction, with US FDA approval for 927 types of trauma products obtained in June 2024.**Trauma & Extremities System**: Implant product lines such as Signex Trauma System and Quantum Plating System, used for trauma and extremity reconstruction. Primarily titanium-based metal implants for hand, foot, arm, and leg fractures and trauma reconstruction, with US FDA approval for 927 types of trauma products obtained in June 2024.
- **Sports Medicine**: Kinex product line for surgical fixation of ligament tissues to bones in joint injuries. Utilizes independently developed biodegradable composite materials (Biocomposite) for optimal biocompatibility and physical strength, eliminating the need for secondary removal surgery. Ten types of sports medicine products received US FDA approval in December 2024.**Sports Medicine**: Kinex product line for surgical fixation of ligament tissues to bones in joint injuries. Utilizes independently developed biodegradable composite materials (Biocomposite) for optimal biocompatibility and physical strength, eliminating the need for secondary removal surgery. Ten types of sports medicine products received US FDA approval in December 2024.
- **Dental**: Products for dental implants and orthodontics, including Optimus D PalaFix palatal plates, torque dental screwdrivers, and dental implant surgery instrument kits. This includes titanium prosthetic devices for orthodontics co-developed with a Yonsei University professor.**Dental**: Products for dental implants and orthodontics, including Optimus D PalaFix palatal plates, torque dental screwdrivers, and dental implant surgery instrument kits. This includes titanium prosthetic devices for orthodontics co-developed with a Yonsei University professor.
- **Spine**: A spinal product lineup launched in 2023, featuring implants used for spinal conditions such as herniated discs. This includes 3D printed titanium spinal implants, which received US FDA approval in March 2026.**Spine**: A spinal product lineup launched in 2023, featuring implants used for spinal conditions such as herniated discs. This includes 3D printed titanium spinal implants, which received US FDA approval in March 2026.
- **Core Technologies**: Ultra-precision metal processing technology capable of controlling precision to 1/1000th of a millimeter, enabling the production of precise structures for implantable medical devices. Expertise in manufacturing biodegradable raw materials and developing bio-absorbable bone fixation devices based on composite polymers.**Core Technologies**: Ultra-precision metal processing technology capable of controlling precision to 1/1000th of a millimeter, enabling the production of precise structures for implantable medical devices. Expertise in manufacturing biodegradable raw materials and developing bio-absorbable bone fixation devices based on composite polymers.
- Core Advantages
- **Extensive Product Portfolio and Full Lineup**: Possession of a wide range of orthopedic implant product lines across CMF, Trauma, Sports Medicine, Dental, and Spine, establishing a comprehensive medical solution from head to toe.**Extensive Product Portfolio and Full Lineup**: Possession of a wide range of orthopedic implant product lines across CMF, Trauma, Sports Medicine, Dental, and Spine, establishing a comprehensive medical solution from head to toe.
- **Innovative Biomaterial Technology**: Proprietary development and application of biodegradable composite materials (Biocomposite), ensuring biocompatibility and optimized physical strength, thereby eliminating the need for secondary removal surgeries.**Innovative Biomaterial Technology**: Proprietary development and application of biodegradable composite materials (Biocomposite), ensuring biocompatibility and optimized physical strength, thereby eliminating the need for secondary removal surgeries.
- **Global Major Partnerships and Distribution Network**: Exclusive supply agreements for sports medicine products with Zimmer Biomet, the world's second-largest orthopedic medical device company, and a supply agreement for neurosurgical products with Germany's B.Braun (Aesculap), securing stable global sales channels and distribution networks.**Global Major Partnerships and Distribution Network**: Exclusive supply agreements for sports medicine products with Zimmer Biomet, the world's second-largest orthopedic medical device company, and a supply agreement for neurosurgical products with Germany's B.Braun (Aesculap), securing stable global sales channels and distribution networks.
- **Ultra-Precision Processing and Manufacturing Capabilities**: Over a decade of technical experience in ultra-precision metal processing, controlling precision to 1/1000th of a millimeter, ensuring high-quality product performance that meets surgical and clinical demands.**Ultra-Precision Processing and Manufacturing Capabilities**: Over a decade of technical experience in ultra-precision metal processing, controlling precision to 1/1000th of a millimeter, ensuring high-quality product performance that meets surgical and clinical demands.
- **US FDA Approvals in Key Markets**: Sequential acquisition of US FDA approvals for core product lines including CMF, Trauma, Sports Medicine, and Spine, facilitating entry into the world's largest medical device market and enhancing competitive advantage.**US FDA Approvals in Key Markets**: Sequential acquisition of US FDA approvals for core product lines including CMF, Trauma, Sports Medicine, and Spine, facilitating entry into the world's largest medical device market and enhancing competitive advantage.
- **Price Competitiveness and Profitability**: Capability to supply high-quality products comparable to major global players at competitive prices, with higher export prices to global partners like Zimmer Biomet contributing significantly to increased operating profit.**Price Competitiveness and Profitability**: Capability to supply high-quality products comparable to major global players at competitive prices, with higher export prices to global partners like Zimmer Biomet contributing significantly to increased operating profit.
- Target Industrie
- Medical Device IndustryMedical Device Industry
- OrthopedicsOrthopedics
- NeurosurgeryNeurosurgery
- Plastic and Oral & Maxillofacial Surgery (CMF Surgery)Plastic and Oral & Maxillofacial Surgery (CMF Surgery)
- Sports Medicine (Joint Preservation)Sports Medicine (Joint Preservation)
- Dentistry (Dental Implants, Orthodontics)Dentistry (Dental Implants, Orthodontics)
- Trauma ReconstructionTrauma Reconstruction
- Spinal Disorder Treatment (Spine)Spinal Disorder Treatment (Spine)
- 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, Singapore, Saudi Arabia, Iran, Syria, Turkey, United Arab Emirates, IraqJapan, India, China, Vietnam, Pakistan, Indonesia, Thailand, Sri Lanka, Hong Kong, Mongolia, Malaysia, Taiwan, Philippines, Singapore, Saudi Arabia, Iran, Syria, Turkey, United Arab Emirates, Iraq
- Germany, Bulgaria, Spain, Lithuania, Russia, Italy, Albania, GreeceGermany, Bulgaria, Spain, Lithuania, Russia, Italy, Albania, Greece
- United States, Mexico, Dominican Republic, GuatemalaUnited States, Mexico, Dominican Republic, Guatemala
- AustraliaAustralia
- Argentina, Chile, Brazil, Colombia, Ecuador, PeruArgentina, Chile, Brazil, Colombia, Ecuador, Peru
- Certifications/Patents
- **US FDA Approvals**: Acquisition of US Food and Drug Administration (FDA) approvals for key product lines, including CMF products (2015), 10 types of sports medicine products (December 2024), 927 types of trauma products (June 2024), and spinal implant products (March 2026).**US FDA Approvals**: Acquisition of US Food and Drug Administration (FDA) approvals for key product lines, including CMF products (2015), 10 types of sports medicine products (December 2024), 927 types of trauma products (June 2024), and spinal implant products (March 2026).
- **Technological Competence**: History of innovative technology development, such as the development of bio-absorbable bone fixation devices based on composite polymers (February 2016), medical composite material technology (January 2017), and orthopedic implant systems with variable angles (October 2018). Capability to produce high-quality, biocompatible medical devices through ultra-precision metal processing technology and the development of biodegradable composite materials.**Technological Competence**: History of innovative technology development, such as the development of bio-absorbable bone fixation devices based on composite polymers (February 2016), medical composite material technology (January 2017), and orthopedic implant systems with variable angles (October 2018). Capability to produce high-quality, biocompatible medical devices through ultra-precision metal processing technology and the development of biodegradable composite materials.
Introduction
Location
38 Digital-ro 29-gil, Guro District, Seoul, South Korea
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