Stryker's Spine Guidance 5 Software featuring Copilot receives 510(k) clearance from FDA
Stryker (NYSE:SYK) has received FDA 510(k) clearance for its Q Guidance System with Spine Guidance 5 Software featuring Copilot. This first-to-market technology integrates smart-powered instruments into Stryker's ecosystem, providing multiple feedback modalities for bone resection, pedicle preparation, and screw delivery. The system includes Smart Zones for bone resection and the Copilot Smart Driver with automatic depth stop for pedicle preparation and screw placement.
Developed with input from over 850 surgeons, this technology aims to enhance surgeon effectiveness and improve patient outcomes. The first clinical cases are set to begin in September, with a full commercial launch expected in fall 2024.
Stryker (NYSE:SYK) ha ricevuto l'approvazione 510(k) dalla FDA per il suo Q Guidance System con Spine Guidance 5 Software e funzionalità Copilot. Questa tecnologia, pionieristica nel suo settore, integra strumenti intelligenti nell'ecosistema di Stryker, fornendo molteplici modalità di feedback per la resezione ossea, la preparazione dei pedicoli e il posizionamento delle viti. Il sistema include Smart Zones per la resezione ossea e il Copilot Smart Driver con arresto automatico della profondità per la preparazione dei pedicoli e il posizionamento delle viti.
Sviluppata con il contributo di oltre 850 chirurghi, questa tecnologia mira a migliorare l'efficacia dei chirurghi e a migliorare i risultati per i pazienti. I primi casi clinici inizieranno a settembre, con un lancio commerciale completo previsto per l'autunno 2024.
Stryker (NYSE:SYK) ha recibido la aprobación 510(k) de la FDA para su Q Guidance System con Spine Guidance 5 Software que incluye Copilot. Esta tecnología, que es la primera en el mercado, integra instrumentos inteligentes en el ecosistema de Stryker, proporcionando múltiples modalidades de retroalimentación para la resección ósea, la preparación del pedículo y la entrega de tornillos. El sistema incluye Smart Zones para la resección ósea y el Copilot Smart Driver con parada automática de profundidad para la preparación del pedículo y la colocación de tornillos.
Desarrollada con la input de más de 850 cirujanos, esta tecnología tiene como objetivo mejorar la efectividad de los cirujanos y los resultados de los pacientes. Los primeros casos clínicos comenzarán en septiembre, con un lanzamiento comercial completo previsto para otoño de 2024.
Stryker (NYSE:SYK)는 Copilot 기능을 갖춘 Spine Guidance 5 소프트웨어와 함께 제공되는 Q Guidance System에 대해 FDA 510(k) 승인을 받았습니다. 이 시장 최초의 기술은 Stryker 생태계에 스마트 파워 도구를 통합하여 뼈 절제, 페디클 준비 및 나사 배치를 위한 다양한 피드백 모드 제공이 가능합니다. 이 시스템은 뼈 절제를 위한 Smart Zones와 페디클 준비 및 나사 배치를 위한 자동 깊이 정지 기능이 있는 Copilot Smart Driver를 포함합니다.
850명이 넘는 외과의사들의 의견을 바탕으로 개발된 이 기술은 외과의사의 효율성을 높이고 환자의 결과를 개선하는 것을 목표로 하고 있습니다. 첫 번째 임상 사례는 9월에 시작될 예정이며, 2024년 가을에 전체 상업 출시가 예상됩니다.
Stryker (NYSE:SYK) a reçu l'autorisation 510(k) de la FDA pour son Q Guidance System avec le logiciel Spine Guidance 5 incluant Copilot. Cette technologie, première sur le marché, intègre des instruments intelligents dans l'écosystème de Stryker, offrant plusieurs modalités de retour d'information pour la résection osseuse, la préparation du pédicule et la livraison des vis. Le système comprend des Smart Zones pour la résection osseuse et le Copilot Smart Driver avec arrêt automatique de profondeur pour la préparation du pédicule et le placement des vis.
Développée avec l'avis de plus de 850 chirurgiens, cette technologie vise à améliorer l'efficacité des chirurgiens et à améliorer les résultats pour les patients. Les premiers cas cliniques devraient débuter en septembre, avec un lancement commercial complet prévu pour l'automne 2024.
Stryker (NYSE:SYK) hat die FDA 510(k) Genehmigung für sein Q Guidance System mit Spine Guidance 5 Software und Copilot erhalten. Diese neuartige Technologie integriert intelligente Instrumente in das Ökosystem von Stryker und bietet mehrere Rückmeldemöglichkeiten für die Knochenresektions-, Pedikels- und Schraubenplatzierung. Das System umfasst Smart Zones für die Knochenresektions und den Copilot Smart Driver mit automatischer Tiefenstop-Funktion zur Pedikelvorbereitung und Schraubenplatzierung.
Entwickelt mit Input von über 850 Chirurgen zielt diese Technologie darauf ab, die Effektivität der Chirurgen zu verbessern und die Patientenoutcomes zu optimieren. Die ersten klinischen Fälle sollen im September beginnen, während ein vollständiger kommerzieller Launch für den Herbst 2024 erwartet wird.
- FDA 510(k) clearance received for Q Guidance System with Spine Guidance 5 Software
- First-to-market technology integrating smart-powered instruments
- Developed with input from over 850 orthopaedic spine surgeons and neurosurgeons
- Automatic depth stop feature is proprietary technology
- Clinical cases to begin in September with full commercial launch expected in fall 2024
- None.
Stryker's FDA clearance for its Q Guidance System with Spine Guidance 5 Software featuring Copilot represents a significant advancement in spinal surgery technology. This first-to-market innovation integrates smart-powered instruments into Stryker's ecosystem, potentially enhancing surgical precision and patient outcomes.
The system's key features include:
- Smart Zones for bone resection with auditory and sensory feedback
- Copilot Smart Driver with automatic depth stop for pedicle preparation and screw placement
- Proprietary technology that works exclusively with Stryker implants
From a market perspective, this innovation could strengthen Stryker's position in the competitive spine surgery market. The extensive involvement of over 850 surgeons in the development process suggests a high likelihood of clinical adoption, which could drive sales growth in Stryker's Spine division.
However, it's important to note that the full commercial launch is slated for later this fall. Investors should closely monitor the initial clinical cases starting in September for early indicators of the technology's performance and adoption rate. The proprietary nature of the technology, working exclusively with Stryker implants, could also create a lock-in effect, potentially boosting long-term revenue streams from both the system and associated implants.
While this development is promising, investors should also consider potential challenges such as the learning curve for surgeons, reimbursement issues and competition from other medical device companies developing similar technologies. The true impact on Stryker's financial performance will likely become clearer in the quarters following the full commercial launch.
As an orthopedic surgeon, I find Stryker's new Q Guidance System with Spine Guidance 5 Software featuring Copilot to be a game-changing innovation in spinal surgery. The integration of smart-powered instruments with multiple feedback modalities addresses several critical challenges we face in the operating room.
The Smart Zones feature for bone resection is particularly impressive. By providing auditory and sensory feedback as we approach planned boundaries of anatomical alert zones, it significantly reduces the risk of inadvertent damage to critical structures. This could potentially lower complication rates and improve patient safety.
The Copilot Smart Driver's automatic depth stop feature is another important advancement. Accurate screw placement is vital in spinal surgery and this technology could enhance precision and reduce the likelihood of screw-related complications. The proprietary nature of this feature, working only with Stryker implants, ensures system integrity but may also limit flexibility for surgeons who prefer to use implants from multiple manufacturers.
However, it's important to note that while these technological advancements are promising, their true value will be determined by real-world clinical outcomes. The learning curve associated with adopting new surgical technologies should not be underestimated. It will be important to monitor early clinical cases and gather data on operative times, complication rates and patient outcomes compared to traditional techniques.
Overall, if this system delivers on its promise, it could significantly improve the standard of care in spinal surgery, potentially leading to better patient outcomes, reduced complications and possibly shorter hospital stays. This could have positive implications not only for patient care but also for healthcare economics.
Q Guidance System with Spine Guidance 5 Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities
LEESBURG, Va. , July 30, 2024 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, today announced that its Q Guidance System with Spine Guidance 5 Software featuring Copilot received 510(k) clearance from the
Spine Guidance Software with Copilot's breakthrough technology was built to provide multiple feedback modalities for supporting bone resection, pedicle preparation and screw delivery to help maximize a surgeon's effectiveness and enhance patient outcomes. Stryker engaged over 850 orthopaedic spine surgeons and neurosurgeons to develop this technology.
"This project is a prime example of our mission in action," said Dylan Crotty, president of Stryker's Instruments division. "We listened to our customers' evolving needs and are engaging leading surgeons to create a product that adds confidence to their workflow."
Smart Zones for bone resection provide auditory and sensory feedback when surgeons approach the planned boundaries of anatomical alert zones with the high-speed drill. To complement Smart Zones, the Copilot Smart Driver** stops automatically when it reaches the planned depth, supporting surgeon precision during pedicle preparation and screw placement. The automatic depth stop feature is proprietary technology that unlocks only when using a Stryker implant.
"Spine Guidance Software with Copilot is just the beginning of our development pipeline," said Robbie Robinson, president of Stryker's Spine division. "While focusing on innovation and the integration of our implants, instrumentation and enabling technologies, we strive to help surgeons perform safe and efficient procedures that enable better patient outcomes."
The first clinical cases using Spine Guidance Software with Copilot will begin in September, with a full commercial launch expected later this fall. For more information on Spine Guidance Software with Copilot please visit https://www.stryker.com/us/en/nse/products/spine-guidance-software-copilot.html.
*Smart features enabled by the Q Guidance System with Spine Guidance 5 Software.
**SPINE-COP-BROC-1169302
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at www.stryker.com.
Media contact
Sarah Yerden
509 438 1198
sarah.yerden@stryker.com
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