DePuy Synthes Receives FDA Clearance for the TriALTIS™ Spine System and Navigation Enabled Instruments
Latest advancement in Spine portfolio delivers next generation thoracolumbar implant system designed for seamless integration with enabling technology
RAYNHAM, Mass. – October 9, 2023 – Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has secured 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the TriALTIS™ Spine System and for TriALTIS™ Navigation Enabled Instruments.
- The TriALTIS™ Spine System is a next generation posterior thoracolumbar pedicle screw system that offers a comprehensive implant portfolio and advanced instrumentation designed for integration with enabling technology.
- TriALTIS™ Navigation Enabled Instruments include drills, taps and screwdrivers that can be operated manually or under power for navigated and non-navigated use.
Combining a new portfolio of implants with a digital ecosystem, the TriALTIS™ Spine System aims to address unmet clinical needs and help surgeons achieve more consistent outcomes in treating complex spine conditions, inclusive of degenerative, tumor, trauma and deformity pathologies.
Spinal deformity is a prevalent disease with some studies suggesting approximately 32% of adults and as high as 68% of adults over the age of 65 are affected.1-4 Age related factors, heterogenous anatomies and complex patient conditions make spinal deformity procedures challenging. As the population ages, spine surgeons are seeing an increasing number of cases with a wide variety of degenerative spinal changes that require instrumented spinal fusion.5 Surgical treatments of patients with adult spinal deformity have been shown to improve patient outcomes, and significantly improve patient pain, health-related quality of life, and overall treatment satisfaction.6
“When it comes to treating complex spinal pathologies, each patient is different, and each case requires its own unique treatment decisions,” said Daniel Sciubba, MD, MBA, Chair & Professor of Neurosurgery at Northwell Health/Hofstra.*** “The TriALTIS™ Spine System offers a comprehensive implant portfolio that complements different anatomies and procedures and can help to streamline surgical workflows and enable intraoperative flexibility – all with the potential to improve clinical experiences.”
Built on a legacy of reliable thoracolumbar solutions and expertise, the TriALTIS™ Spine System was developed with a hyper focus on performance and a consistent user experience. The inclusive and forward-looking design philosophy of the TriALTIS™ Spine System affords smooth integration with cement augmentation, power, navigation and robotic-assisted solutions.
“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,” said Russell Powers****, Worldwide President, Spine, DePuy Synthes. “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.”
DePuy Synthes expects the TriALTIS™ Spine System to be available in the U.S. in 2024. For more information about DePuy Synthes Spine specialty products, read more here.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more information, visit https://thenext.jnjmedtech.com/
About DePuy Synthes
DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow. For more information, visit www.depuysynthes.com.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the TriALTIS™ Spine System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, Inc., Medical Device Business Services, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of DePuy Synthes, Inc., Medical Device Business Services, Inc., nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
* Comprising the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
** DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
*** Daniel Sciubba, MD, MBA is a paid consultant for DePuy Synthes and was involved in the design trials for the TriALTIS™ System.
**** Russell Powers is an employee of Medical Device Business Services, Inc.
Please refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions.
259580-231005 DSUS
© DePuy Synthes 2023. All rights reserved.
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- Parenteau C, Lau E, Campbell I, et al. Prevalence of spine degermation diagnosis by type, age, gender, and obesity using Medicare data. Scientific Reports. 2021, 11:5389. DOI.
- Diebo B, Shah N, Boachie-Adjei O, et al. Adult Spinal Deformity. The Lancet. 2019;394:160-72.
- Passias P., Brown A., Bortz C., et al. Increasing Cost Efficiency in Adult Spinal Deformity Surgery. SPINE. 2022. Vol47:1. 21-26. DOI: 10.1097/BRS.0000000000004201
- Zygourakis C, Liu C, Keefe M et al. Analysis of National Rates, Cost, and Sources of Cost Variation in Adult Spinal Deformity. Neurosurgery. 2018. DOI: 10.1093/neuros/nyx218.
- Martin-Fernandez M., Lopez-Herradon, Pinera A, et al. Potential risks of using cement-augmented screws for spinal fusion in patients with low bone quality. The Spine Journal. 2017, 1192-119. DOI
- Stephens B, Khan I, Chotai S, et al. Drivers of Cost in Adult Thoracolumbar Spine Deformity Surgery. World Neurosurgery. 2018. 118:e206-e221. DOI
