Additive Manufacturing (AM), or 3D printing technology, is triggering a profound technological revolution in the global orthopedic field. With its personalized, precise, and rapid manufacturing capabilities, 3D printing is now widely applied in orthopedic implants, surgical guides, bone tissue engineering scaffolds, and more. This article systematically explores its current applications in orthopedics, leading foreign enterprises, indications, and development trends, aiming to provide strategic insights for overseas AM companies entering the Chinese market.
As population aging intensifies and the incidence of orthopedic diseases rises, the demand for orthopedic care continues to grow. Traditional implants are typically standardized in design, making it difficult to fully conform to patients’ anatomical structures, which affects surgical outcomes. In contrast, 3D printing enables personalized design and precise manufacturing of implants based on CT or MRI data, significantly improving fit and postoperative recovery. Moreover, 3D printing supports the rapid prototyping of complex structures, shortening product development cycles and enhancing R&D efficiency.
Global Trends in Additive Manufacturing for Orthopedics
Currently, 3D printing in orthopedics is primarily applied in the following areas:
- Orthopedic implants, including joint replacements, intervertebral fusion devices, and cranio-maxillofacial reconstructions.
- Preoperative planning and surgical guides, by printing affected areas and custom guides to assist surgeons in precise operations.
- Bone tissue engineering scaffolds, which provide support and guidance for bone defect repair and tissue regeneration.
- Education and training, by producing realistic anatomical models to enhance teaching efficiency and hands-on experience.
The additive manufacturing market continues to grow rapidly. According to the American Academy of Orthopedic Surgeons, the global orthopedic 3D printing device market is expected to increase by approximately $1.35 billion between 2023 and 2028. Two major trends are emerging:
- Process and Material Innovation:
Metal 3D printing (e.g., titanium alloy SLM, electron beam melting EBM) is used to create porous metal implants to promote osseointegration. High-performance polymers like PEEK (polyether ether ketone) have also made breakthroughs. In 2024, U.S.-based 3D Systems received FDA approval for the first 3D-printed PEEK cranial implant system (VSP® PEEK Cranial Implant), manufactured using the EXT 220 MED printer and Evonik’s PEEK resin. This system reduces material use by 85% and demonstrates AM’s advantages in complex cranial reconstructions.
3D Systems’ VSP® PEEK skull implant, the first FDA-approved 3D-printed PEEK implant. The system demonstrates the potential to significantly reduce traditional processing material waste through customized design and additive production.
Many companies are expanding the use of PEEK, PEKK, and other medical-grade plastics in applications such as spinal fusion cages and trauma plates.
- Enhanced Production Efficiency and Intelligence:
Multi-laser powder bed fusion systems and sheet-based inkjet printing significantly increase output.
Post-processing techniques like hot isostatic pressing and surface passivation improve device quality.
On the software side, AI-assisted automatic modeling and surgical planning systems have matured, streamlining the workflow from imaging to implantation.
Emerging innovations—such as metal binder jetting, carbon-fiber-reinforced materials, and biodegradable scaffolds—are entering clinical research stages, signaling greater diversification in orthopedic 3D printing devices and applications. These systems also highlight AM’s potential to reduce material waste through custom design and digital production.
Five Leading Global AM Companies
The current global AM market is led by five companies:
| Company | Representative Products / Technologies | Technical Features |
| 3D Systems (USA) | EXT 200/220 series metal printers, ProX plastic series; VSP® orthopedic surgical planning and spinal fusion cages | Specializes in customized implants and surgical guides; integrates software design and manufacturing capabilities; multiple FDA clearances (e.g., ankle guides). |
| Stratasys (USA) | FDM systems (e.g., F370/F900), PolyJet systems (e.g., J5/J85) | Strong color printing capability with biocompatible materials (e.g., ABS-M30i); suitable for complex anatomical models and surgical guides; focuses on full medical 3D printing ecosystems. |
| EOS (Germany) | DMLS systems, EOS P series polymer SLS systems | High industrial stability; supports medical-grade materials like titanium alloys and CoCr; capable of producing porous structures to facilitate bone ingrowth. |
| GE Additive (USA) | Electron beam melting systems (e.g., Arcam EBM), laser melting systems (e.g., Concept Laser Q10plus) | High-temperature builds reduce residual stress; optimized for mass production of titanium hip and knee implants with advanced lattice structures; known for precision. |
| Smith & Nephew (UK) | 3D-printed titanium orthopedic implants, such as REDAPT™ Revision Hip System and LEGION™ knee components | Focuses on patient-specific implants and revision joint reconstruction; uses proprietary porous structures (e.g., TRABECULAR METAL™-like design) to enhance osseointegration and implant longevity. |
