Summary
2024 was a groundbreaking year for 3D Systems in advancing PEEK 3D printing, marked by FDA clearance for patient-specific cranial implants and over 60 successful cranioplasties worldwide. The EXT 220 MED printer and expanded PEEK material portfolio are enabling versatile, patient-specific solutions, from cranio-maxillo-facial implants to orthopedic applications, revolutionizing personalized care. Looking to 2025, 3D Systems aims to lead further innovation in PEEK for spinal, orthopedic, and surgical applications, solidifying its role in transforming healthcare with precision and customization.
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Elevating Patient Care: PEEK 3D Printing’s Leap in 2024
As we look back on 2024, it’s been a monumental year for 3D Systems in healthcare, particularly in the field of PEEK (Polyetheretherketone) 3D printing. PEEK has been emerging as one of the most sought-after materials for medical devices due to its key characteristics, such as biocompatibility, similarity of its mechanical properties to bone, and radiolucency.
The EXT 220 MED printer from 3D Systems is paving the way for using this material for patient-specific care – it is the only healthcare-dedicated printer that supports printing with PEEK materials.
Groundbreaking FDA Clearance for 3D-printed PEEK Cranial Implants
One of our most notable achievements in 2024 was the FDA 510(k) clearance for our VSP® PEEK Cranial Implants. It is the world’s first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures. This is a win for the new era of patient-specific, customized, high-quality medical devices.
It is not just the implant itself – it is a complete FDA-cleared workflow, with a pre-defined production process that starts from transforming 2D patient images into 3D data (segmentation), goes through 3D modeling, and gets produced on the EXT 220 MED 3D printer with Evonik VESTAKEEP® i4 3DF PEEK. Through our experiences in achieving FDA clearance, 3D Systems can consult with OEMs and point-of-care sites to establish patient-specific PEEK implant manufacturing processes.
Discover more about how 3D Systems achieved the regulatory clearance in the PEEK Implants Printing Pathway to Clearance webinar. You can also refer to our official press release for more details.
Adoption at Points of Care: 60+ Cranioplasty Surgeries Performed
With the initial start of expansion of PEEK printing at points of care in 2023 (learn more in the 3D Systems’ Extrusion Technology to Produce Patient-specific PEEK Implants Supports Ground-breaking Cranial Surgeries at Leading European Hospitals article), by the end of 2024 the workflow has been used to enable more than 65 successful cranioplasties in clinics and hospitals, including in Switzerland at University Hospital Basel, in Austria at Salzburg University Hospital (learn more about their first surgery in this article), and in Israel at Tel-Aviv Sourasky Medical Center.
Medical device manufacturers as well are already looking into 3D printing in PEEK to optimize their production. You can learn more about fast-tracking medical device path to the market in this webinar.
Expanding the PEEK Materials Portfolio for a Wider Use
One of the reasons PEEK has been progressively gaining attention over the past decade is its incredible versatility. PEEK can be enhanced with different fillers, allowing to modify its properties to match specific clinical needs.
For example, standard (or virgin) PEEK is likely to be used for cranio-maxillo-facial applications due to its bone-like elasticity, biologically inert nature, and radiolucency. In contrast, barium sulfate-enhanced PEEK is used in implants requiring radiopacity, allowing surgeons to monitor their placement through X-ray or fluoroscopy.
BCP-PEEK (biphasic calcium phosphate PEEK) and HA-PEEK (hydroxyapatite PEEK), infused with bioactive minerals, are ideal for orthopedic implants that require bone ingrowth. These materials are associated with promotion of implant's osseointegration and mimicking bone mineral content. CFR-PEEK, reinforced with carbon fibers, provides enhanced strength for applications that require stiffer implants like fracture plates or cervical plates.
These variants ensure the material aligns with the mechanical, biological, and diagnostic needs of each specific application. 2024 saw the extensive testing and fine-tuning of printing parameters for the above-mentioned types of PEEK, now arming medical device OEMs and point-of-care sites with more and more power to create patient-specific medical devices for various indications.
Next Stop: PEEK Spine Cages
In 2024, 3D Systems has launched a proprietary process to manufacture porous PEEK spine cages. Such implants can be produced with an integrated lattice structure for better osseointegration. In this application, biphasic calcium phosphate enhanced PEEK is used with an intent to promote cell attachment and cell proliferation.
The Lookout on 2025: The Year of PEEK
Additive production of patient-specific devices in PEEK has already started to redefine the healthcare (just read the PEEK-ing into the Future: How 3D Printing is Redefining Cranial Implants article in the ODT Magazine). Looking ahead, we believe 2025 will be the year where PEEK truly shines. Our collaborations with medical professionals around the world are driving forward research and development of new applications. We are committed to pushing the boundaries further, expanding our material portfolio and applications to meet even more specialized needs.
Whether it's spinal implants, orthopedic components, or cranial repair, we believe PEEK – backed by 3D Systems' innovation – will continue transforming patient-specific care and surgical outcomes in 2025. We’re proud to be at the forefront of this journey, setting new standards in personalized and precise medical solutions.
Learn more about our innovative PEEK solutions and the EXT 220 MED printer or follow us on social media where we share updates and news. Connect with our experts to see how our technology can meet your medical needs by reaching out through our Contact Us page.