Smith+Nephew is pioneering Spatial Surgery – a defining new Sports Medicine category pushing the boundaries of technology and procedural innovation
Smith+Nephew (NYSE:SNN) has announced its pioneering initiative in Spatial Surgery, introducing the TESSA◊ Spatial Surgery System pending FDA clearance. The system combines real-time tracking with NVIDIA® GPU technology to assist surgeons during anterior cruciate ligament reconstruction (ACLR) procedures.
The technology aims to address a significant clinical need, as technical error is the second most common reason for ACLR failure, with femoral (29%) and tibial (11%) tunnel malposition being the primary causes. TESSA would provide personalized planning, augmented reality, and real-time data processing to help surgeons navigate operative plans during procedures.
If cleared by the FDA, TESSA would be indicated for anterior cruciate ligament surgical knee procedures where stereotactic surgery may be appropriate and reference to rigid anatomical bony structures can be determined.
Smith+Nephew (NYSE:SNN) ha annunciato la sua iniziativa pionieristica in Chirurgia Spaziale, introducendo il Sistema di Chirurgia Spaziale TESSA◊ in attesa dell'approvazione della FDA. Il sistema combina il tracciamento in tempo reale con la tecnologia GPU di NVIDIA® per assistere i chirurghi durante le procedure di ricostruzione del legamento crociato anteriore (ACLR).
La tecnologia mira a soddisfare un'importante esigenza clinica, poiché l'errore tecnico è la seconda causa più comune di fallimento dell'ACLR, con la malposizione dei tunnel femorali (29%) e tibiali (11%) che rappresentano le cause principali. TESSA fornirebbe pianificazione personalizzata, realtà aumentata e elaborazione dei dati in tempo reale per aiutare i chirurghi a seguire i piani operativi durante le procedure.
Se approvato dalla FDA, TESSA sarebbe indicato per le procedure chirurgiche al ginocchio del legamento crociato anteriore dove la chirurgia stereotassica potrebbe essere appropriata e dove è possibile fare riferimento a strutture ossee anatomiche rigide.
Smith+Nephew (NYSE:SNN) ha anunciado su iniciativa pionera en Cirugía Espacial, presentando el Sistema de Cirugía Espacial TESSA◊ pendiente de la aprobación de la FDA. El sistema combina el seguimiento en tiempo real con la tecnología GPU de NVIDIA® para asistir a los cirujanos durante los procedimientos de reconstrucción del ligamento cruzado anterior (ACLR).
La tecnología tiene como objetivo abordar una necesidad clínica significativa, ya que el error técnico es la segunda razón más común para el fallo del ACLR, siendo la malposición de los túneles femorales (29%) y tibiales (11%) las causas principales. TESSA proporcionaría planificación personalizada, realidad aumentada y procesamiento de datos en tiempo real para ayudar a los cirujanos a navegar por los planes operativos durante los procedimientos.
Si es aprobado por la FDA, TESSA estaría indicado para procedimientos quirúrgicos de rodilla del ligamento cruzado anterior donde la cirugía estereotáctica podría ser apropiada y se puede determinar la referencia a estructuras óseas anatómicas rígidas.
Smith+Nephew (NYSE:SNN)는 공간 수술 분야에서 혁신적인 이니셔티브를 발표하며, TESSA◊ 공간 수술 시스템을 FDA 승인을 기다리고 있습니다. 이 시스템은 실시간 추적 기능과 NVIDIA® GPU 기술을 결합하여 전방 십자인대 재건(ACLR) 수술 중에 외과의를 지원합니다.
이 기술은 임상적 필요를 충족하는 것을 목표로 하며, 기술적 오류는 ACLR 실패의 두 번째로 흔한 원인으로, 대퇴골(29%) 및 경골(11%) 터널의 잘못된 위치가 주요 원인입니다. TESSA는 개인 맞춤형 계획, 증강 현실 및 실시간 데이터 처리를 제공하여 외과의사가 수술 중에 운영 계획을 탐색하는 데 도움을 줄 것입니다.
FDA의 승인을 받으면 TESSA는 스테레오택틱 수술이 적합할 수 있는 전방 십자인대 수술에 적합할 것이며, 강직한 해부학적 뼈 구조에 대한 참조를 결정할 수 있습니다.
Smith+Nephew (NYSE:SNN) a annoncé son initiative pionnière en Chirurgie Spatiale, présentant le Système de Chirurgie Spatiale TESSA◊ en attente de l'approbation de la FDA. Le système combine le suivi en temps réel avec la technologie GPU de NVIDIA® pour aider les chirurgiens lors des procédures de reconstruction du ligament croisé antérieur (ACLR).
La technologie vise à répondre à un besoin clinique significatif, car l'erreur technique est la deuxième raison la plus courante de l'échec de l'ACLR, les malpositions des tunnels fémoraux (29%) et tibiaux (11%) étant les principales causes. TESSA fournirait une planification personnalisée, une réalité augmentée et un traitement des données en temps réel pour aider les chirurgiens à naviguer dans les plans opératoires pendant les procédures.
Si approuvé par la FDA, TESSA serait indiqué pour les procédures chirurgicales du ligament croisé antérieur au genou où la chirurgie stéréotaxique pourrait être appropriée et où il est possible de se référer à des structures osseuses anatomiques rigides.
Smith+Nephew (NYSE:SNN) hat seine bahnbrechende Initiative in Räumlicher Chirurgie angekündigt und führt das TESSA◊ Räumliche Chirurgiesystem ein, das auf die Genehmigung durch die FDA wartet. Das System kombiniert Echtzeit-Tracking mit NVIDIA® GPU-Technologie, um Chirurgen während der Rekonstruktion des vorderen Kreuzbands (ACLR) zu unterstützen.
Die Technologie zielt darauf ab, einen erheblichen klinischen Bedarf zu decken, da technische Fehler die zweithäufigste Ursache für das Versagen von ACLR sind, wobei die Hauptursachen die Fehlpositionierung des femoralen (29%) und tibialen (11%) Tunnels sind. TESSA würde personalisierte Planung, erweiterte Realität und Echtzeit-Datenverarbeitung bieten, um Chirurgen bei der Navigation durch operative Pläne während der Eingriffe zu unterstützen.
Wenn von der FDA genehmigt, wäre TESSA für chirurgische Eingriffe am Knie des vorderen Kreuzbands angezeigt, bei denen stereotaktische Chirurgie angemessen sein könnte und auf starre anatomische Knochenstrukturen verwiesen werden kann.
- FDA submission completed for innovative TESSA surgical system
- Addresses significant clinical need with 40% failure rate in ACLR procedures
- Integration of advanced technology (NVIDIA GPU, AR) in surgical procedures
- Product still pending FDA clearance
- initial application to only ACLR procedures
- Success and market adoption rates unknown
Insights
Smith+Nephew's advancement into Spatial Surgery represents a strategic move to differentiate in the competitive orthopedic market. The pending FDA submission for the TESSA◊ Spatial Surgery System marks their commitment to higher-margin technological solutions rather than competing solely on implant pricing.
This technology targets anterior cruciate ligament reconstruction (ACLR), a procedure performed approximately 100,000+ times annually in the US alone. By addressing technical errors that account for
While the financial impact remains uncertain pending FDA clearance, this development aligns with the company's long-term strategy of expanding their digital surgery capabilities. The collaboration with NVIDIA for GPU processing power suggests Smith+Nephew is building sustainable technological advantages rather than pursuing incremental improvements.
Investors should note this represents a forward-looking R&D investment rather than an immediate revenue driver. The orthopedic market increasingly values technologies that improve procedural consistency and outcomes, potentially positioning Smith+Nephew well if they can demonstrate clinical and economic advantages through this platform.
The TESSA system targets a significant clinical challenge in ACL reconstruction. Currently, technical errors in tunnel positioning account for
Smith+Nephew's approach combines several advanced technologies: real-time tracking, GPU-powered processing, and augmented reality guidance. This integration creates a comprehensive surgical assistant that bridges the gap between pre-operative planning and intraoperative execution – something particularly valuable in arthroscopic procedures where direct visualization is
The system's focus on rigid anatomical landmarks suggests reliable registration capabilities, a historical challenge in surgical navigation. However, the technology will face practical implementation hurdles including OR workflow integration, learning curves for surgical teams, and demonstrating sufficient value to justify adoption costs.
What distinguishes this from earlier surgical navigation attempts is the emphasis on real-time data processing and augmented reality rather than simply tracking instruments. If cleared and properly executed, this could represent a significant evolution in arthroscopic surgery practices beyond traditional navigation approaches.
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces its pioneering efforts to develop technology in the field of Spatial Surgery - a revolutionary new frontier in arthroscopic surgical innovation. We envision Spatial Surgery as an opportunity to provide personalized planning, augmented reality and real-time data processing into platforms that interpret the surgical field intraoperatively.
Smith+Nephew has submitted to the FDA a traditional 510(k) for a technology called the TESSA◊ Spatial Surgery System. If cleared by the FDA, TESSA (Tracking Enabled Spatial Surgery Assistant) would combine a real-time, tracking-enabled device powered by a NVIDIA® GPU. By using video processing and augmented reality guidance, TESSA would assist a surgeon in making anterior cruciate ligament reconstruction (ACLR) femoral tunnel decisions by navigating an operative plan.
TESSA is currently pending FDA clearance with proposed indications for use in anterior cruciate ligament surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. Technical error is the second most common reason for ACLR failure, with femoral (
“We are excited to unveil our vision for Spatial Surgery – shaping the future of arthroscopic surgery by empowering healthcare professionals to utilize advanced technologies for patient personalization,” said Scott Schaffner, President of Global Sports Medicine at Smith+Nephew. “Challenging the status quo is what we do best, and we look forward to continuing the conversation and integrating Spatial Surgery as a core Sports Medicine discipline if cleared by the FDA.”
To learn more about how Smith+Nephew plans to lead the way with Spatial Surgery for Sports Medicine, please visit our booth (#3729) at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in San Diego March 11-13, 2025. Stay tuned to https://spatialsurgery.com for further developments.
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Media Enquiries
Dave Snyder +1 (978) 749-1440
Smith+Nephew david.snyder@smith-nephew.com
References
1. Li X, Yan L, Li D, et al. Failure modes after anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Int Orthop. 2023;47(3):719–734.
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.
Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of
For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.
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FAQ
What is the TESSA Spatial Surgery System that Smith+Nephew (SNN) has submitted to FDA?
What clinical problem does Smith+Nephew's TESSA system aim to address?
When will Smith+Nephew (SNN) showcase the Spatial Surgery technology?
What are the proposed indications for Smith+Nephew's TESSA system?
