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| Naji, M. |
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| Motta, Antonella |
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| Aletan, Dirar |
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| Mohamed, Tarek |
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| Ertürk, Emre |
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| Taccardi, Nicola |
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| Kononenko, Denys |
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| Petrov, R. H. | Madrid |
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| Alshaaer, Mazen | Brussels |
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| Bih, L. |
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| Casati, R. |
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| Muller, Hermance |
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| Kočí, Jan | Prague |
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| Šuljagić, Marija |
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| Kalteremidou, Kalliopi-Artemi | Brussels |
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| Azam, Siraj |
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| Ospanova, Alyiya |
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| Blanpain, Bart |
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| Ali, M. A. |
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| Popa, V. |
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| Rančić, M. |
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| Ollier, Nadège |
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| Azevedo, Nuno Monteiro |
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| Landes, Michael |
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| Rignanese, Gian-Marco |
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Gill, H. S.
University of Bath
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (18/18 displayed)
- 2024Experiments and numerical modelling of secondary flows of blood and shear-thinning blood analogue fluids in rotating domainscitations
- 2024Auxetic fixation devices can achieve superior pullout performances compared to standard fixation conceptscitations
- 2021Properties of PMMA end cap holders affect FE stiffness predictions of vertebral specimens
- 20213D Printed Medical Grade Ti-6Al-4V Osteosynthesis Devices Meet the Requirements for Tensile Strength, Bending, Fatigue and Biocompatibility
- 2019Evaluating strength of 3D printed screw threads for patient-specific osteosynthesis plates
- 2019Evaluation of optimised cervical spine viscoelastic elements for sport injury analysis
- 2018The effect of plate design, bridging span, and fracture healing on the performance of high tibial osteotomy plates – an experimental and finite element study.citations
- 2017Validated cemented socket model for optimising acetabular fixation
- 2017Effect of absorbed fatty acids on physical properties of ultra-high molecular weight polyethylene
- 2017Use of contrast agents on polymeric materials
- 2016A Python Package to Assign Material Properties of Bone to Finite Element Models from within Abaqus Software
- 2016An open source software tool to assign the material properties of bone for ABAQUS finite element simulationscitations
- 2016A validated specimen specific finite element model of vertebral body failure
- 2016Variations in Cortical Thickness of Composite Femur Test Specimens
- 2015Tibial Fracture after Unicompartmental Knee Replacement: The Importance of Surgical Cut Accuracy
- 2014Classification of retinal ganglion cells in the southern hemisphere lamprey Geotria australis (Cyclostomata)citations
- 2014Effect of Q-switched laser surface texturing of titanium on osteoblast cell response
- 2013Fracture of mobile unicompartmental knee bearingscitations
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document
3D Printed Medical Grade Ti-6Al-4V Osteosynthesis Devices Meet the Requirements for Tensile Strength, Bending, Fatigue and Biocompatibility
Abstract
Objectives<br/>Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. <br/>The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).<br/>Methods <br/>All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO 6892-1, ISO 9585 and ISO 12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO 10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK).<br/>Results <br/>The mechanical tests demonstrated that the material performed to the specification for conventionally manufactured titanium alloy of this type (ISO 5832-3). The toxicology review concluded that there were no significant concerns for the health of the patients identified in this evaluation and implantation of the TOKA® device would not result in a significant health risk to patients.<br/>Conclusions<br/>Reflecting on our MHRA experience, additive manufacture of orthopaedic devices is still considered to be a ‘novel’ process by regulatory bodies, requiring additional safety evidence. Despite this, our findings demonstrate that there is no difference, mechanically or chemically, to the traditionally manufactured alloy material. We hope to support the widening use of 3D printed titanium alloy orthopaedic devices by publishing our route to regulatory approval.<br/>