Spinal Frontiers · Medtech & Innovation · How It's Made
Engineering, manufacture and materials science of spinal implants, from 3D-printed titanium cages to the tests every screw-rod system must pass.
How spinal implants and instruments are designed, made and tested, and the materials science behind them. Good independent material exists on materials, testing standards and regulation, and on how 3D-printed cages are made. Step-by-step accounts of machining a pedicle screw or coating a cage come mostly from contract manufacturers and equipment makers: we list the clearest of them and mark them Commercial. Standards are sold by ASTM and ISO; their pages show the scope free.
From titanium powder and bar stock to a finished, sterile implant: additive manufacturing of porous cages, machining, coatings, cleaning and sterilisation.
Garg et al., Journal of Functional Biomaterials (MDPI), 2026
Narrative review of how 3D-printed lattice interbody cages are designed and made, which materials are used and how ready they are for the clinic. Flags manufacturing issues such as residual powder trapped in porous structures. CC BY.
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Guo et al., Frontiers in Bioengineering and Biotechnology, 2025
Explains how additive manufacturing controls pore size, porosity and geometry in titanium implants, and surveys surface treatments and coatings, with spinal applications included. Open access.
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Majumdar, Eisenstein, Frith, Cox, Birbilis; Advanced Engineering Materials, 2018 (University of Birmingham repository)
Compares selective laser melting, directed energy deposition and electron beam melting for titanium implants, covering lattice design, mechanical properties and new low-stiffness alloys. The journal version is paywalled; the repository page links a free accepted manuscript.
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Pehlivan et al., Materials (MDPI), 2020
Original research rather than a review: tests hot isostatic pressing and chemical etching on laser-melted porous titanium. A useful look at the post-print steps (removing loose powder, heat treatment) that rarely get explained. CC BY.
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BONEZONE (sponsored content by Viant Medical), 2021
Walks through how artificial discs are made at a contract manufacturer: precision machining, CMM inspection, mirror polishing, titanium and HA plasma spray, ultrasonic cleaning, ISO 8 cleanroom packaging and sterilisation. Promotional, written by the manufacturer.
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SME (article by Stephan Zeidler, GE Additive)
Plain-language comparison of laser and electron-beam powder bed fusion, with spinal cages as a worked example of porosity reducing stiffness and stress shielding. Written by a machine supplier, so it reads as advocacy.
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US Food and Drug Administration (FDA)
Official overview of how additive manufacturing works for implants and instruments, including patient-specific devices, with links to guidance and outside resources such as ASTM F42.
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US Food and Drug Administration (FDA)
FDA's recommendations on design, process validation, testing and characterisation for devices with at least one additively manufactured part. The basic reference for how 3D-printed cages are expected to be controlled.
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US Food and Drug Administration (FDA)
Official overview of the sterilisation methods used for devices: steam, dry heat, radiation, ethylene oxide, vaporised hydrogen peroxide and newer methods. Covers the effort to reduce reliance on ethylene oxide.
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International Organization for Standardization (ISO)
The standard for sterile barrier and packaging systems that must keep an implant sterile until it is used. Only the catalogue page is free; the standard costs CHF 196.
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Life Science Outsourcing (LSO)
A contract service page that sets out the post-machining steps a spinal implant goes through: decontamination and cleaning, cleanroom assembly and kitting, packaging, UDI labelling and sterilisation. Light on detail, but a clear map of the process.
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ODT Magazine (Orthopedic Design & Technology), Sam Brusco
Trade feature in which suppliers describe changes in how spinal implants are made: 3D-printed porous PEEK and titanium, automated CNC machining, shorter lead times for patient-specific implants, nearshoring and single-use instrument sets. Includes some market commentary.
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Why spinal implants are made of what they are made of: titanium alloys, PEEK and carbon-fibre PEEK, tantalum, ceramics and resorbable metals, and how bone grows onto them.
ASTM International
The core material specification for implant-grade Ti-6Al-4V ELI: chemistry, mechanical and metallurgical requirements. The current version is F136-26 (February 2026). Catalogue page with scope is free; the standard costs USD 72.
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International Organization for Standardization (ISO)
The international counterpart to ASTM F136 for Ti-6Al-4V used in implants. Catalogue page is free; the standard costs CHF 67.
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ASTM International
Material specification for Ti-6Al-4V ELI parts made by powder bed fusion, the route used for most 3D-printed titanium cages. Catalogue page is free; the standard costs USD 72.
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ASTM International
The specification for implant-grade PEEK resin. Catalogue page is free; the standard costs USD 72.
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International Organization for Standardization (ISO)
The sixth edition (2025) of the framework for assessing biocompatibility within risk management; it replaced the 2018 edition. Catalogue page is free; the standard costs CHF 196.
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Prasad et al., Materials (MDPI), 2017
Readable survey of stainless steel, titanium alloys, cobalt-chromium, tantalum and the biodegradable metals (magnesium, zinc, iron), with their surface and bulk modifications. CC BY.
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Zhang et al., Frontiers in Bioengineering and Biotechnology, 2022
Spine-specific review of cage materials (titanium, tantalum, PEEK, magnesium, absorbable polymers, ceramics), cage design and post-processing such as coatings and fillers. Open access.
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Wang et al., Frontiers in Bioengineering and Biotechnology, 2023
Explains how porous tantalum is made (foam impregnation, chemical vapour deposition, additive manufacturing) and treated, with a section on spinal use. Open access.
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Zhi et al., Metals (MDPI), 2022
History, manufacturing routes (machining, laser melting, wire-arc additive manufacturing) and corrosion-control coatings of resorbable magnesium implants, and why fast degradation is still the main obstacle. CC BY.
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Zhu, Wang and Li, Materials Advances (Royal Society of Chemistry), 2021
Groups surface treatments for titanium implants (spinal cages included) into mechanical, physical, chemical and biological methods, including nanotubes, coatings and antibacterial approaches. Open access, CC BY-NC.
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Isaacson and Jeyapalina, Orthopedic Research and Reviews (Dove), 2014
Primer on how bone bonds to an implant: surface, host bone, primary stability, micromotion and loading. Not spine-specific, but a clear foundation. Open-access publisher; the page does not state the licence.
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Ghermandi et al. (Rizzoli Institute), Bioengineering (MDPI), 2023
A clinical pilot case series (28 patients), not a review. Included because it explains why carbon-fibre PEEK screws and rods are used (radiolucency, bone-like stiffness). Small, uncontrolled study. CC BY.
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Rahaman and Xiao, International Journal of Applied Ceramic Technology, 2018 (Missouri S&T Scholars' Mine record)
Review of silicon nitride as an implant ceramic, including spinal fusion use, surface tuning and antibacterial behaviour. Paywalled: the repository holds only the citation.
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MIT OpenCourseWare (Prof. Anne Mayes)
Free undergraduate course with lecture notes, problem sets and exams on metals, polymers and ceramics used in the body, surface modification and tissue response. CC BY-NC-SA 4.0. Older material, but the fundamentals hold.
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MIT OpenCourseWare (Profs. Ioannis Yannas and Myron Spector)
Free graduate course on how tissues respond to implants and prostheses, including porous surfaces for ingrowth. Lecture notes and exams available. CC BY-NC-SA 4.0.
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How a new screw-rod system or cage is tested before it reaches theatre: the ASTM spinal test methods, FDA guidance and computer modelling.
ASTM International
The benchmark static and fatigue test for pedicle screw–rod and plate constructs. The catalogue page explains scope and significance; the standard costs USD 104.
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ASTM International
Static and dynamic compression, compression-shear and torsion tests used to compare interbody cage designs. The current version is F2077-24. Catalogue page is free; the standard costs USD 80.
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ASTM International
Mechanical test methods for disc arthroplasty devices; it does not cover wear, expulsion or debris response. The active version is F2346-18(2026). Catalogue page is free; the standard costs USD 72.
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ASTM International
The committee that writes the implant material and spinal test standards. The page links to its subcommittees and work items, so readers can see how standards are made and get involved.
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US Food and Drug Administration (FDA)
What FDA expects in a 510(k) for rod and plate systems and vertebral body replacements: device description, mechanical testing, sterility and labelling. Final guidance.
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US Food and Drug Administration (FDA)
Special controls that came with the reclassification of interbody fusion devices to Class II, including the performance testing expected for titanium and polymer cages.
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Wang and Wu, Frontiers in Bioengineering and Biotechnology, 2023
Reviews finite element studies of cage materials, porosity and topology optimisation, fixation and fusion techniques, and names the common shortcomings of these models. Open access.
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Injury and Reconstruction Biomechanics Test Suite, Imperial College London
University test lab page with diagrams of the set-ups for ASTM F2077, F2267 (subsidence), F2346 and an expulsion test, including which test-block materials are used and why.
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Element Materials Technology
Commercial test lab's plain-English description of F2077, F2267, F1717, F2706 and F1798, including run-out to 5 million cycles and wear-debris analysis. Notes that additively manufactured implants need extra evaluation.
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Instron (test-equipment maker)
Short explainer on subsidence testing and how the test is set up. Written by an equipment vendor that recommends its own machines.
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The quality and regulatory rules every implant maker works under, from the official sources.
International Organization for Standardization (ISO)
The quality-management standard for organisations that design and make devices; reconfirmed in 2025. Catalogue page and FAQ are free; the standard costs CHF 196.
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US Food and Drug Administration (FDA)
Explains the amended 21 CFR 820, in force since 2 February 2026, which incorporates ISO 13485:2016 by reference and keeps design-control requirements.
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US Food and Drug Administration (FDA)
FDA's long-standing guidance on design controls (inputs, outputs, verification, validation, design review). It predates the QMSR, so read it alongside the QMSR page.
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US Food and Drug Administration (FDA)
How UDIs are put on labels and on devices, and how device data reach the GUDID database. Includes the public AccessGUDID search.
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EUR-Lex, Publications Office of the European Union
The official text of the MDR. Annexes II and III set out the technical documentation a manufacturer must hold. Free to read on EUR-Lex.
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European Commission, Public Health
The official index of MDCG guidance for applying the MDR, by topic: classification, clinical evaluation, notified bodies, UDI, post-market surveillance and more.
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European Commission, Public Health
How the EU UDI system works: the device and production identifiers, manufacturers' duties, the designated issuing entities and the EUDAMED database.
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Medicines and Healthcare products Regulatory Agency (MHRA), GOV.UK
How devices reach the Great Britain and Northern Ireland markets: MHRA registration, the UK Responsible Person, UKCA and CE marking, and the transition dates. Updated February 2026.
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Courses, societies, trade magazines, conferences and podcasts for anyone who wants to go further, including surgeons who work with industry.
University of Leeds, on FutureLearn
A two-week self-paced short course on implant design, materials, manufacturing, testing and regulation, then regenerative alternatives. Free for four weeks; paid upgrade for a certificate. Mostly about joints, but the principles carry over to spine.
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Delft University of Technology (edX MOOC)
Six-module MOOC on EU device classification, CE conformity, Annex I, ISO 14971 risk analysis and clinical research. The course page does not state whether a free audit track exists.
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Society For Biomaterials
Professional society with an Orthopaedic Biomaterials special interest group, student chapters, mentoring and webinars; co-hosts the 2028 World Biomaterials Congress.
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European Society for Biomaterials
European biomaterials society with an annual meeting (2026 in Antwerp), a young scientists' forum and affiliated national societies.
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Institution of Mechanical Engineers
The UK's largest group of professional biomedical engineers, many in device design and manufacture; it runs seminars, regional centres and a student project competition.
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American Society of Mechanical Engineers
Engineering community behind the Journal of Biomechanical Engineering and the Summer Bioengineering Conference, with committees on solid mechanics and design.
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Orthopaedic Research Society
Research society for engineers and surgeons, with a Spine Section, the journal JOR Spine and a spine research symposium.
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BONEZONE / ORTHOWORLD
The orthopaedic industry's manufacturing conference; the 2026 edition ran 9–11 June with more than 225 suppliers and sessions on supply chain, R&D and additive manufacturing. 2027 dates were not yet confirmed. Commercial trade event.
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ODT Magazine
Trade magazine on orthopaedic device design and manufacture: materials, machining, moulding, sterilisation and testing. Articles appear readable without payment, but the site does not state its terms.
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ORTHOWORLD Inc.
Orthopaedic product-development publication for R&D engineers, covering additive manufacturing, materials and suppliers. Some pieces are sponsored.
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Medical Design & Outsourcing (Arrowfly LLC)
Trade publication on device design, development and manufacturing. Much of its spine content is company news, so pick articles with care.
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MPO
Medtech manufacturing and outsourcing magazine covering cleanliness validation, 3D printing and regulatory topics.
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Interviews with Technical People (podcast)
An engineering manager at a spinal implant company explains how implants are designed and made, including 3D printing and titanium alloys. The guest's employer is a manufacturer.
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DeviceTalks (Arrowfly LLC)
Medtech industry podcasts. DeviceTalks Weekly is the main show; several series are sponsored by companies, including an orthopaedic one, so treat those as commercial.
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Greenlight Guru (QMS software company)
Long-running podcast on design controls, ISO 13485, CAPA, risk and audits. Produced by a software vendor.
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Easy Medical Device (Monir El Azzouzi)
Regulatory podcast on EU MDR, CE marking, technical documentation and QMS. Run by a consultancy.
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Seeing it done. Few spine makers publish factory videos; these show the same processes.
ASME (video produced by ASME; features Stryker)
Video by a professional body showing metal 3D printing of porous titanium implants at Stryker's Cork plant, and the years of validation before production. About joints rather than spine, but the process is the same one used for porous cages. Features a manufacturer.
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Additive Manufacturing magazine (Gardner Business Media)
Trade-magazine video in which a spinal implant maker shows its workflow for 3D-printed PEEK cervical implants and makes the point that printing is only one step. May need a free sign-in. Features a manufacturer.
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Additive Manufacturing magazine (Gardner Business Media)
Short clip on why titanium is usually chosen for spinal implants and where PEEK may have the edge (stiffness, radiolucency). Features a manufacturer.
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Orchid Orthopedic Solutions (contract manufacturer, now combined with Tecomet)
Manufacturer's news page (November 2024) introducing a video tour of electron beam melting at its additive plant.
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We found no independent, step-by-step film of a spinal implant being made, from bar stock to sterile pack. If you work in spine manufacturing or run a test lab and would show how it is done, or know a good open resource, write to spinalfrontiers@nspine.com.
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