The Art and Engineering of Implants

Redefining the Face: The Art and Engineering of Implants

As technology continues to advance and transportation speeds increase, traumatic head injuries have become more prevalent. According to the NIH, an estimated 69 million individuals suffer a traumatic brain injury each year, and this number continues to rise [1]. The high incidence of cranial trauma underscores the need for individualized implants tailored to each patient’s anatomy and injury. Kelyniam Global Inc. aims to address this need with the release of the Fusion™ Cranial and Craniofacial Implants, the first major new cranial and craniofacial implant system in eight years.

Kelyniam Global uses 3D printing to produce patient-specific implant models and employs CNC machining for precision matching. They are the only manufacturer with a patented integrated fixation system, enabling surgeons to secure implants with screws directly in the operating room and reducing the need for additional plating.

Biphasic Calcium Phosphate (BCP) has become a well-known bone graft substitute due to its composition of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), which can be tuned in composition depending on clinical needs. HA provides structural stability, while β-TCP is more soluble and supports bone remodelling. BCP is widely used in dental implants and performs well in vivo. Polyether Ether Ketone (PEEK), the other material component, is a high-performance thermoplastic, offering excellent strength, wear resistance, and temperature stability. It is lightweight, biocompatible, has a flexural modulus similar to cortical bone, and is radiolucent, making it invisible on X-ray, CT, and MRI. These material properties contribute to the implant’s clinical effectiveness and appeal.

The recently approved implant combines BCP with a PEEK reinforcement structure. This hybrid design supports bone growth and osseointegration, while still allowing for rapid patient-specific production. These implants can be designed, printed, and shipped within 24–48 hours. Beyond traumatic brain injury repair, they can also be used to address defects resulting from tumor resections or congenital abnormalities. With companies like Kelyniam advancing individualized craniofacial reconstruction, trauma repair is entering a new and more individualized era.

Article written by Jennifer Joanna-Joan Villeneuve.

Image courtesy of Kelyniam Global Inc

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