AccScience Publishing / IJB / Online First / DOI: 10.36922/IJB026240248
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REVIEW ARTICLE

Clinical translation of 3D-bioprinted orthopedic grafts: Design specifications, evaluation domains, and regulatory considerations for bone, cartilage, and osteochondral repair

Yuan Chen1,2† Shuheng Yang3† Jiaqi Chen1 Minggan Guo1,2 Yahan Li1,2 Zhongyi Sun2* Fanchun Zeng2*
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1 Guangdong Key Laboratory for Biomedical Measurements and Ultrasound Imaging, National-Regional Key Technology Engineering Laboratory for Medical Ultrasound, School of Biomedical Engineering, Medical School, Shenzhen University, Shenzhen, Guangdong , China
2 Central Laboratory, Renji Hospital, School of Medicine, Chongqing University, Chongqing , China
3 Department of Urology, Dali Bai Autonomous Prefecture People’s Hospital (Yunnan West Central Hospital), Dali, Yunnan , China
†These authors contributed equally to this work.
Received: 9 June 2026 | Revised: 12 July 2026 | Accepted: 21 July 2026 | Published online: 22 July 2026
© 2026 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
Abstract

Three-dimensional (3D) bioprinting has advanced rapidly, but clinical translation of orthopedic grafts remains constrained by a mismatch between printable constructs and indication-specific failure modes. Bone, cartilage, and osteochondral defects impose distinct requirements: vascularized remodeling and load sharing for bone, phenotypic stability and low-friction durability for cartilage, and mechanically integrated compartmental organization for osteochondral repair. This narrative review synthesizes recent evidence on 3D-bioprinted orthopedic grafts with a translational focus on design specifications, validation endpoints, manufacturing control, and regulatory readiness. Rather than treating bioinks, printing platforms, and cell sources as isolated technologies, the review organizes them according to clinical function: structural support, biological instruction, process control, maturation, immune compatibility, and product qualification. Current evidence indicates that many constructs remain validated mainly by early biological markers, representative imaging, or short-term animal outcomes, whereas clinically relevant tests of fatigue, wear, degradation-coupled mechanics, host–graft integration, vascular perfusion, immune response, sterility, dimensional tolerances, and release criteria are less consistently reported. Near-term translation appears most plausible for acellular or minimally cellular reinforced constructs, patient-specific but quality-testable bone scaffolds, and selected intraoperative applications with clear surgical utility. More complex living grafts that combine vascular, immune-instructive, and multi-tissue functions will require stronger preclinical models, standardized reporting, and product-specific regulatory strategies. Translation in orthopedic bioprinting should begin with the clinical failure mode and proceed toward measurable release specifications, not with printability alone.

Keywords
3D bioprinting
Orthopedic regeneration
Bone defect
Cartilage repair
Osteochondral interface
Vascularization
In situ bioprinting
Regulatory science
Funding
This research was supported by the Shenzhen Science and Technology Program (JCYJ20220531103004008), the Talent Introduction Program of Renji Hospital Affiliated to Chongqing University (2025_0071), and the Scientific and Technological Research Program of Chongqing Municipal Education Commission (KJQN202600124).
Conflict of interest
The authors declare that they have no competing interests.
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International Journal of Bioprinting, Electronic ISSN: 2424-8002 Print ISSN: 2424-7723, Published by AccScience Publishing