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REVIEW
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Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review

Changning Sun1,2 ,  Jianfeng Kang3 ,  Chuncheng Yang1 ,  Jibao Zheng1,2 ,  Yanwen Su1,2 ,  Enchun Dong1,2 ,  Yingjie Liu1,2 ,  Siqi Yao1,2 ,  Changquan Shi1 ,  Huanhao Pang1,2 ,  Jiankang He1,2 ,  Ling Wang1,2* ,  Chaozong Liu4 ,  Jianhua Peng5 ,  Liang Liu5 ,  Yong Jiang5 ,  Dichen Li1,2*
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1 State Key Laboratory for Manufacturing System Engineering, School of Mechanical Engineering, Xi’an Jiaotong University, Xi’an, Shaanxi Province, China
2 National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Additive Manufacturing Medical Devices, Xi’an Jiaotong University, Xi’an, Shaanxi Province, China
3 Jihua Laboratory, Foshan, Guangdong Province, China
4 Institute of Orthopaedic & Musculoskeletal Science, University College London, Royal National Orthopaedic Hospital, Stanmore, UK
5 Department of Neurosurgery, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan Province, China
BMT 2022 , 3(2), 116–133; https://doi.org/10.12336/biomatertransl.2022.02.001
Submitted: 26 January 2022 | Revised: 9 March 2022 | Accepted: 8 June 2022 | Published: 28 June 2022
Copyright © 2022 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution–NonCommercial–ShareAlike 4.0 License.
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Abstract

Polyether-ether-ketone (PEEK) is believed to be the next-generation biomedical material for orthopaedic implants that may replace metal materials because of its good biocompatibility, appropriate mechanical properties and radiolucency. Currently, some PEEK implants have been used successfully for many years. However, there is no customised PEEK orthopaedic implant made by additive manufacturing licensed for the market, although clinical trials have been increasingly reported. In this review article, design criteria, including geometric matching, functional restoration, strength safety, early fixation, long-term stability and manufacturing capability, are summarised, focusing on the clinical requirements. An integrated framework of design and manufacturing processes to create customised PEEK implants is presented, and several typical clinical applications such as cranioplasty patches, rib prostheses, mandibular prostheses, scapula prostheses and femoral prostheses are described. The main technical challenge faced by PEEK orthopaedic implants lies in the poor bonding with bone and soft tissue due to its biological inertness, which may be solved by adding bioactive fillers and manufacturing porous architecture. The lack of technical standards is also one of the major factors preventing additive-manufactured customised PEEK orthopaedic implants from clinical translation, and it is good to see that the abundance of standards in the field of additive-manufactured medical devices is helping them enter the clinical market.

Keywords
3D printing
additive manufacturing
customised implant
polyether-ether-ketone
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Conflict of interest
The authors declare they have no competing interests.
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