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Johnson & Johnson Launches VIRTUGUIDE� AI-Powered Patient-Matched Lapidus System in U.S. to Reduce Complexity in Bunion Surgery for Millions

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Johnson & Johnson (NYSE:JNJ) has launched the VIRTUGUIDE� System, an AI-powered solution for bunion surgery that received FDA 510(k) clearance earlier this year. The system, designed for Lapidus procedures, uses pre-operative planning software developed with PeekMed® to create personalized surgical recommendations.

Early adopters report 30-minute reductions in surgical time compared to traditional techniques. The technology addresses a significant medical need, as bunions affect approximately one-third of U.S. adults. The VIRTUGUIDE� System joins J&J's VELYS� Enabling Tech solutions portfolio, aiming to streamline surgical procedures and improve accuracy through patient-matched instrumentation.

Johnson & Johnson (NYSE:JNJ) ha lanciato il Sistema VIRTUGUIDE�, una soluzione basata sull'intelligenza artificiale per la chirurgia del alluce valgo, che ha ottenuto l'autorizzazione FDA 510(k) all'inizio di quest'anno. Il sistema, progettato per le procedure di Lapidus, utilizza un software di pianificazione pre-operatoria sviluppato con PeekMed® per creare raccomandazioni chirurgiche personalizzate.

I primi utilizzatori segnalano una riduzione di 30 minuti nel tempo chirurgico rispetto alle tecniche tradizionali. Questa tecnologia risponde a una necessità medica importante, dato che l'alluce valgo colpisce circa un terzo degli adulti statunitensi. Il Sistema VIRTUGUIDE� si aggiunge al portafoglio di soluzioni VELYS� Enabling Tech di J&J, con l'obiettivo di semplificare le procedure chirurgiche e migliorare la precisione grazie a strumenti personalizzati per il paziente.

Johnson & Johnson (NYSE:JNJ) ha lanzado el Sistema VIRTUGUIDEā„�, una solución impulsada por inteligencia artificial para la cirugĆ­a de juanetes que recibió la aprobación FDA 510(k) a principios de este aƱo. El sistema, diseƱado para procedimientos Lapidus, utiliza un software de planificación preoperatoria desarrollado con PeekMedĀ® para crear recomendaciones quirĆŗrgicas personalizadas.

Los primeros usuarios reportan una reducción de 30 minutos en el tiempo quirĆŗrgico en comparación con las tĆ©cnicas tradicionales. La tecnologĆ­a responde a una necesidad mĆ©dica significativa, ya que los juanetes afectan aproximadamente a un tercio de los adultos en EE.UU.. El Sistema VIRTUGUIDEā„� se une al portafolio de soluciones VELYSā„� Enabling Tech de J&J, con el objetivo de optimizar los procedimientos quirĆŗrgicos y mejorar la precisión mediante instrumentación adaptada al paciente.

Johnson & Johnson (NYSE:JNJ)ėŠ� ģ˜¬ķ•“ ģ“� FDA 510(k) ģŠ¹ģøģ� ė°›ģ€ 씱저근막ģ—� 수술ģš� AI 기반 ģ†”ė£Øģ…˜ģø VIRTUGUIDEā„� ģ‹œģŠ¤ķ…�ģ� ģ¶œģ‹œķ–ˆģŠµė‹ˆė‹¤. ģ� ģ‹œģŠ¤ķ…œģ€ Lapidus 수술 절차ė„� ģœ„ķ•“ ģ„¤ź³„ė˜ģ—ˆģœ¼ė©°, PeekMedĀ®ź³� ķ•Øź»˜ 개발ķ•� 수술 ģ � ź³„ķš ģ†Œķ”„ķŠøģ›Øģ–“ė„¼ ģ‚¬ģš©ķ•˜ģ—¬ ź°œģø ė§žģ¶¤ķ˜� 수술 ź¶Œź³ ģ•ˆģ„ ģ œź³µķ•©ė‹ˆė‹�.

쓈기 ģ‚¬ģš©ģžė“¤ģ€ 기씓 기법ģ—� 비핓 수술 ģ‹œź°„ģ� 30ė¶� ė‹Øģ¶•ė˜ģ—ˆė‹¤ź³  ė³“ź³ ķ•©ė‹ˆė‹�. ģ� źø°ģˆ ģ€ 미국 ģ„±ģøģ� ģ•� 3ė¶„ģ˜ 1ģ� ģ”±ģ €ź·¼ė§‰ģ—¼ģœ¼ė”� ź³ ķ†µė°›ėŠ” ģ¤‘ģš”ķ•� ģ˜ė£Œ ģˆ˜ģš”ė„� ķ•“ź²°ķ•©ė‹ˆė‹�. VIRTUGUIDEā„� ģ‹œģŠ¤ķ…œģ€ J&Jģ� VELYSā„� Enabling Tech 솔루ģ…� ķ¬ķŠøķ“ė¦¬ģ˜¤ģ— ķ•©ė„˜ķ•˜ģ—¬, ķ™˜ģž ė§žģ¶¤ķ˜� 기구ė„� 통핓 수술 절차ė„� ź°„ģ†Œķ™”ķ•˜ź³� ģ •ķ™•ģ„±ģ„ ķ–„ģƒģ‹œķ‚¤ėŠ� ź²ƒģ„ ėŖ©ķ‘œė”� ķ•©ė‹ˆė‹�.

Johnson & Johnson (NYSE:JNJ) a lancĆ© le SystĆØme VIRTUGUIDEā„�, une solution alimentĆ©e par l'intelligence artificielle pour la chirurgie des oignons, qui a reƧu l'autorisation FDA 510(k) plus tĆ“t cette annĆ©e. Ce systĆØme, conƧu pour les procĆ©dures de Lapidus, utilise un logiciel de planification prĆ©opĆ©ratoire dĆ©veloppĆ© avec PeekMedĀ® pour crĆ©er des recommandations chirurgicales personnalisĆ©es.

Les premiers utilisateurs rapportent une réduction de 30 minutes du temps opératoire par rapport aux techniques traditionnelles. Cette technologie répond à un besoin médical important, car les oignons affectent environ un tiers des adultes américains. Le Système VIRTUGUIDE� rejoint le portefeuille de solutions VELYS� Enabling Tech de J&J, visant à simplifier les procédures chirurgicales et à améliorer la précision grâce à une instrumentation adaptée au patient.

Johnson & Johnson (NYSE:JNJ) hat das VIRTUGUIDEā„� System eingeführt, eine KI-gestützte Lƶsung für die Operation von Hallux valgus, die Anfang dieses Jahres die FDA 510(k) Zulassung erhalten hat. Das System, das für Lapidus-Verfahren entwickelt wurde, verwendet eine prƤoperative Planungssoftware, die in Zusammenarbeit mit PeekMedĀ® entwickelt wurde, um personalisierte chirurgische Empfehlungen zu erstellen.

Erstanwender berichten von 30 Minuten kürzeren Operationszeiten im Vergleich zu herkƶmmlichen Techniken. Die Technologie adressiert einen bedeutenden medizinischen Bedarf, da Hallux valgus etwa ein Drittel der erwachsenen US-Bevƶlkerung betrifft. Das VIRTUGUIDEā„� System ergƤnzt das VELYSā„� Enabling Tech Lƶsungsportfolio von J&J, mit dem Ziel, chirurgische AblƤufe zu optimieren und die Genauigkeit durch patientenangepasste Instrumente zu verbessern.

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Insights

J&J's VIRTUGUIDE� AI system streamlines bunion surgery with patient-matched precision, potentially impacting a large market while reducing OR time.

Johnson & Johnson's new VIRTUGUIDEā„� System represents a significant advancement in orthopedic surgical technology, specifically targeting Lapidus procedures for bunion correction. The AI-powered, patient-matched solution addresses a substantial market opportunity, considering bunions affect approximately one-third of U.S. adults—translating to roughly 110 million Americans.

The system's value proposition centers on reducing surgical complexity through personalized pre-operative planning and customized instrumentation. Early adopters report procedural time savings of at least 30 minutes compared to traditional techniques, which translates to significant operating room efficiency gains. This time reduction could potentially allow for more procedures per day, benefiting both healthcare facilities and patients through reduced anesthesia exposure.

From a technical perspective, the VIRTUGUIDE� System leverages the PeekMed® collaboration to create personalized surgical recommendations, suggesting J&J is prioritizing strategic partnerships to accelerate innovation in its orthopedic portfolio. The system's recent FDA 510(k) clearance validates its safety profile and positions it for immediate commercialization.

This launch strengthens J&J's position in the extremities segment of orthopedics, complementing their broader VELYS� technology ecosystem. For a company generating approximately $28 billion in medical device revenue annually, innovations targeting high-prevalence conditions like bunions represent meaningful opportunities for market expansion in the fragmented orthopedic extremities space.

Early VIRTUGUIDE� surgeons report a 30-minute reduction in surgical time versus traditional treatment1,2,*,**

WEST CHESTER, Penn., July 29, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) ā€“ĢżJohnson & Johnson MedTech, a global leader in orthopaedic technologies and solutions, today announced the launch of the VIRTUGUIDEā„� System. This AI-powered, patient-matched solution is designed to support Lapidus procedures2, a type of bunion surgery that helps realign the foot by joining two bones near the arch (the first metatarsal bone and the medial cuneiform).3ĢżThe system uses pre-operative planning software, developed in collaboration with PeekMedĀ®, to assess each patient's bunion and make personalized recommendations for the intended correction.2

Bunions are among the most common foot problems, affecting nearly one-third of adults in the U.S.4, yet traditional Lapidus surgery to treat the condition is often challenging.5,6ĢżThe VIRTUGUIDEā„� AI Lapidus System addresses this by enabling a streamlined approach and reducing surgical complexity.2**ĢżEarly users estimated procedural time savings of at least 30 minutes when using the system compared to their previous technique.1,*

"VIRTUGUIDEā„� has completely transformed my approach to bunion surgery, making a complex Lapidus procedure significantly easier and faster. Since adopting VIRTUGUIDEā„�, my surgical corrections have been spot-on—what I plan preoperatively is exactly what I achieve in the operating room," said Michael Campbell, M.D., FAAOS, a board-certified orthopaedic surgeon at Atlantic Orthopaedic Specialists.± "This improved accuracy leads to better outcomes, and the ability to present the pre-operative plan to my patients helps address their questions and ease their concerns§."

"The VIRTUGUIDEā„� System is a pivotal advancement in AI-powered surgical precision for treating bunion deformities—a common, painful, and potentially debilitating condition affecting nearly one-third of Americans4," said Oray Boston, Worldwide President of Trauma, Extremities, Craniomaxillofacial, Animal Health and Sports Medicine, Orthopaedics,ĢżJohnson & JohnsonĢżMedTech. "This milestone marks an important step forward, as VIRTUGUIDEā„� becomes the latest addition to our growing portfolio of VELYSā„� Enabling Tech solutions. By automating surgical planning and tailoring instrumentation to each patient, the system helps reduce complexity in the operating room and helps surgeons to achieve the intended correction2,7**."

This launch follows the 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Pre-operative Planning Software, granted earlier this year.‖Ģ�The system is now available in the U.S.ĢżFor more information, visit .

Orthopaedic Solutions from Johnson & Johnson MedTechĢż
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. In Orthopaedics, we are on a mission to keep people moving by leveraging our deep expertise in joint reconstruction, robotics and enabling tech, spine, sports, trauma, and extremities, to develop the next generation of medtech solutions. We offer one of the most comprehensive Orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. For more, visit our Ģżor follow us on .Ģż

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at . Follow us at Ģżand on . DePuy Synthes Products, Inc. is a Johnson & Johnson company.

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 VIRTUGUIDEā„� 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 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 most recent Annual Report on Form 10-K, 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 , Ģżor on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Important Information: Prior to use, refer to the instructions for use supplied with the device(s) or indications, contraindications, warnings and precautions.

Ā© Johnson & Johnson and its affiliates 2025. All rights reserved. US_ORT_FTAK_398543

* Statements are based on responses from 10 surgeons, having completed a total of 150 Lapidus procedures using the VIRTUGUIDE� System. The statements reflect surgeon experience, not clinical outcomes, and were included if at least 6 surgeons agreed.
** VIRTUGUIDE� System compared to Treace Medical Lapiplasty® 3-Plane System and Paragon28 Bun-Yo-Matic Lapidus Clamp System.
± Dr. Michael Campbell, M.D., FAAOS is a paid consultant for Johnson & Johnson MedTech.
§These statements reflect the experience, approach and opinion of the surgeon.
ā€–ĢżThe VIRTUGUIDEā„� Planning Software, powered by PeekMedĀ®, is developed and owned by Peek Health, S.A. Refer to help.peekmed.com for user manuals, FAQ's, or any support.
The third-party trademarks used herein are trademarks of their respective owners.

1ĢżJohnson & Johnson MedTech, VIRTUGUIDEā„� System Early Surgeon Experience Report December 2024, Windchill Document# EM24-0028
2ĢżJohnson & Johnson and its affiliatesĢżVIRTUGUIDEā„� System Feature Memo. 9th Dec 2024. Windchill # EM24-0027.
3ĢżAmerican Orthopaedic Foot & Ankle Society. Lapidus Procedure. FootCareMD. Accessed June 24, 2025. Ģż
4ĢżMedlinePlus. Bunion: Genetic and Environmental Causes. U.S. National Library of Medicine. Available at . Accessed March 2025.
5ĢżRupke T. The modified Lapidus procedure for the treatment of moderate to severe hallux valgus. Orthogate. Published October 30, 2013. Accessed June 26, 2025.
6ĢżForan IM, Lin J, Hamid KS, Lee S. Technical tip: kerfing for Lapidus arthrodesis: deformity correction with minimal bone resection. J Foot Ankle Surg. 2021;60(2):424-427. doi:10.1053/j.jfas.2020.10.004
7ĢżSobrón FB, Santos-Vaquinhas AD, Alonso B, et al. Technique tip: 3D printing surgical guide for pes cavus midfoot osteotomy. J Foot and Ankle Surgery. 2022;28:371-377.Ģż

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FAQ

What is the VIRTUGUIDE� System by Johnson & Johnson (NYSE:JNJ)?

VIRTUGUIDE� is an AI-powered, patient-matched system designed for Lapidus bunion procedures that uses pre-operative planning software to assess each patient's condition and provide personalized surgical recommendations.

How much time does the VIRTUGUIDE� System save during bunion surgery?

Early users of the system report saving at least 30 minutes in procedural time compared to their previous surgical technique.

When did Johnson & Johnson receive FDA clearance for VIRTUGUIDE�?

The VIRTUGUIDE� System received FDA 510(k) clearance for its Pre-operative Planning Software earlier in 2025.

What percentage of U.S. adults are affected by bunions?

Bunions affect nearly one-third of adults in the United States, making it one of the most common foot problems.

How does VIRTUGUIDE� improve bunion surgery outcomes?

The system improves outcomes by enabling streamlined surgical approaches, reducing complexity, and providing accurate pre-operative planning that matches actual surgical results.
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