DePuy Synthes, the orthopaedic company of Johnson & Johnson (J&J), has received the US Food and Drug Administration (FDA) 510(k) approval for its TriALTIS spine system and TriALTIS Navigation Enabled Instruments.

The TriALTIS Spine System is an advanced posterior thoracolumbar pedicle screw system that includes a complete implant portfolio and advanced instrumentation.

It combines a new portfolio of implants with a digital ecosystem to address unmet clinical needs and help spine surgeons achieve consistent outcomes in treating complex conditions.

The TriALTIS Navigation Enabled Instruments comprise drills, taps and screwdrivers that can be selected manually or under power for navigated and non-navigated use.

DePuy Synthes Worldwide spine president Russell Powers said: “The TriALTIS Spine System will be our premier pedicle screw platform designed to work seamlessly across our entire DePuy Synthes portfolio of enabling technology solutions.

“Johnson & Johnson MedTech is proud to deliver this exciting innovation that can help facilitate the surgical treatment of spinal degeneration and deformity with the goal to improve fixation, drive better patient outcomes and potentially reduce the clinical and economic burden associated with the current standard of care.

“DePuy Synthes has been a leader in the complex spine space for over 35 years, and the launch of the TriALTIS Spine System will mark a critical milestone towards our vision to continue this legacy long into the future.”

Spinal deformity is a prevalent disease, and its treatment procedures are challenging due to age-related factors, heterogenous anatomies and complex patient conditions.

The number of cases with different degenerative spinal changes, requiring instrumented spinal fusion is increasing with the age of the population.

The surgical treatments for adult spinal deformity would improve patient outcomes, patient pain, health-related quality of life, and overall treatment satisfaction.

DePuy Synthes said that its TriALTIS Spine System has been developed with an enhanced focus on performance and consistent user experience.

It has an inclusive and progressive design philosophy that enables smooth integration with cement augmentation, power, navigation, and robotic-assisted solutions.

The orthopaedics company intends to commercialise the TriALTIS spine system in the US, starting in 2024.