DePuy Synthes Receives FDA Clearance for TriLEAP™ Lower Extremity Anatomic Plating System
DePuy Synthes Will Bring Low-profile Plating System to Hospitals and Surgeons to Cover Forefoot, Midfoot and Hindfoot Elective and Trauma Procedures
WEST CHESTER, Penn. – October 11, 2023 – Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TriLEAP™ Lower Extremity Anatomic Plating System, a comprehensive yet modular, procedure-specific system designed to meet the complex needs of orthopaedic surgeons, doctors of podiatric medicine, and foot and ankle specialists. The TriLEAP™ System provides a diverse offering of contoured and conventional plates that can accommodate multiple screw diameters, and instruments that can be used during the reduction, internal fixation and fusion of bones and bone fragments.
Elective foot surgeries for conditions like bunions are among the fast-growing segments of extremities procedures in orthopaedics and podiatry. In the U.S., one in four people suffer from bunions, or hallux valgus, a progressive disorder of the foot in which deformity gradually increases and can eventually compromise desired lifestyle or mobility.1 Foot and ankle plating systems are implants that are used for bunionectomies, osteotomies, fusions and fractures of the foot or ankle. The systems are attached by surgeons to the affected area and are designed to stabilize the bones.
The TriLEAP™ Lower Extremity Anatomic Plating System offers multiple procedure-specific plate options to cover a wide range of procedures, as well as an extensive procedure‐specific implant choice with multiple screw shaft diameters that provide surgeons with various options for intraoperative decisions.
“As a leader in elective foot and ankle procedures, DePuy Synthes is dedicated to developing novel solutions tailored to the changing needs of both patients and surgeons,” said Oray Boston***, Worldwide President, DePuy Synthes Trauma, Extremities, Craniomaxillofacial, Animal Health and Sports. “The development and clearance of the TriLEAP™ Lower Extremity Anatomic Plating System is a prime example of how we are maintaining our speed of innovation in the space to address unmet needs and help achieve the best possible outcomes for patients.”
DePuy Synthes expects the TriLEAP™ Lower Extremity Anatomic Plating System to be available in the U.S. in 2024. For more information on the TriLEAP™ System and other
DePuy Synthes Foot & Ankle 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 TriLEAP™ Lower Extremity Anatomic Plating 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 either
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.
***Oray Boston 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.
© DePuy Synthes 2023. All rights reserved.
1Roddy E, Weiya Z, Doherty M. Prevalence and associations of hallux valgus in a primary care population. Arthritis Care & Research 2008 59(6):857-862