Monogram Technologies Announces World鈥檚 First Fully Autonomous Saw-Based Robotic Knee Replacement Surgery
Monogram Technologies (NASDAQ: MGRM) has achieved a historic milestone by completing the world's first fully autonomous saw-based robotic knee replacement surgery on a live patient. The groundbreaking procedure was performed on July 26, 2025, at Krishna Shalby Hospital in Ahmedabad, India, using Monogram's mB么s TKA System.
The surgery is part of a 102-patient multi-center clinical trial in India, approved by CDSCO, evaluating the system's safety and effectiveness. The procedure utilized the Consensus CKS implant, which is substantially equivalent to Monogram's mPress implants. This achievement follows the recent FDA 510(k) clearance for Monogram's semi-autonomous TKA System and comes amid Zimmer Biomet's (NYSE: ZBH) pending acquisition of Monogram.
Monogram Technologies (NASDAQ: MGRM) ha raggiunto un traguardo storico completando il primo intervento chirurgico al mondo di sostituzione del ginocchio completamente autonomo con sega robotica su un paziente in vita. La procedura innovativa 猫 stata eseguita il 26 luglio 2025 presso l'ospedale Krishna Shalby di Ahmedabad, in India, utilizzando il sistema mB么s TKA di Monogram.
L'intervento fa parte di uno studio clinico multicentrico su 102 pazienti in India, approvato dal CDSCO, che valuta la sicurezza e l'efficacia del sistema. La procedura ha impiegato l'impianto Consensus CKS, sostanzialmente equivalente agli impianti mPress di Monogram. Questo risultato segue la recente approvazione FDA 510(k) per il sistema TKA semi-autonomo di Monogram e arriva in un momento in cui Zimmer Biomet (NYSE: ZBH) sta per acquisire Monogram.
Monogram Technologies (NASDAQ: MGRM) ha alcanzado un hito hist贸rico al completar la primera cirug铆a de reemplazo de rodilla totalmente aut贸noma con sierra rob贸tica en un paciente vivo. El procedimiento innovador se realiz贸 el 26 de julio de 2025 en el Hospital Krishna Shalby en Ahmedabad, India, utilizando el sistema mB么s TKA de Monogram.
La cirug铆a forma parte de un ensayo cl铆nico multic茅ntrico con 102 pacientes en India, aprobado por CDSCO, que eval煤a la seguridad y efectividad del sistema. El procedimiento utiliz贸 el implante Consensus CKS, que es sustancialmente equivalente a los implantes mPress de Monogram. Este logro sigue a la reciente aprobaci贸n FDA 510(k) para el sistema TKA semiaut贸nomo de Monogram y se produce en medio de la adquisici贸n pendiente de Monogram por parte de Zimmer Biomet (NYSE: ZBH).
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鞚� 靾橃垹鞚� CDSCO鞚� 鞀轨澑鞚� 氚涭潃 鞚鸽弰 雮� 102氇� 頇橃瀽 雼り赴甏� 鞛勳儊鞁滍棙鞚� 鞚柬櫂鞙茧, 鞁滌姢韰滌潣 鞎堨爠靹标臣 須臣毳� 韽夑皜頃╇媹雼�. 靾橃垹鞐愲姅 Monogram鞚� mPress 鞛勴攲霝�韸胳檧 鞁れ鞝侅溂搿� 霃欕摫頃� Consensus CKS 鞛勴攲霝�韸戈皜 靷毄霅橃棃鞀惦媹雼�. 鞚措矆 靹标臣電� 斓滉芳 Monogram鞚� 氚橃瀽鞙� TKA 鞁滌姢韰滌棎 雽�頃� FDA 510(k) 鞀轨澑 鞚错泟 鞚措（鞏挫鞙茧┌, Zimmer Biomet (NYSE: ZBH)鞚� Monogram鞚� 鞚胳垬頃橂姅 瓿检爼 欷戩棎 鞚措（鞏挫鞀惦媹雼�.
Monogram Technologies (NASDAQ : MGRM) a franchi une 茅tape historique en r茅alisant la premi猫re chirurgie de remplacement du genou enti猫rement autonome, bas茅e sur une scie robotis茅e, sur un patient vivant. Cette proc茅dure r茅volutionnaire a 茅t茅 effectu茅e le 26 juillet 2025 脿 l'h么pital Krishna Shalby d'Ahmedabad, en Inde, en utilisant le syst猫me mB么s TKA de Monogram.
Cette chirurgie fait partie d'un essai clinique multicentrique portant sur 102 patients en Inde, approuv茅 par le CDSCO, 茅valuant la s茅curit茅 et l'efficacit茅 du syst猫me. La proc茅dure a utilis茅 l'implant Consensus CKS, qui est substantiellement 茅quivalent aux implants mPress de Monogram. Cette r茅ussite fait suite 脿 la r茅cente validation FDA 510(k) du syst猫me TKA semi-autonome de Monogram et intervient alors que Zimmer Biomet (NYSE : ZBH) est en cours d'acquisition de Monogram.
Monogram Technologies (NASDAQ: MGRM) hat einen historischen Meilenstein erreicht, indem es die weltweit erste vollst盲ndig autonome, s盲gebasierte robotergest眉tzte Kniegelenkersatzoperation an einem lebenden Patienten erfolgreich durchgef眉hrt hat. Der bahnbrechende Eingriff fand am 26. Juli 2025 im Krishna Shalby Hospital in Ahmedabad, Indien, unter Verwendung des mB么s TKA Systems von Monogram statt.
Die Operation ist Teil einer multizentrischen klinischen Studie mit 102 Patienten in Indien, die von der CDSCO genehmigt wurde und die Sicherheit und Wirksamkeit des Systems bewertet. Dabei wurde das Consensus CKS Implantat verwendet, das dem mPress-Implantat von Monogram im Wesentlichen entspricht. Dieser Erfolg folgt auf die k眉rzliche FDA 510(k)-Zulassung des halbautonomen TKA-Systems von Monogram und erfolgt im Zuge der bevorstehenden 脺bernahme von Monogram durch Zimmer Biomet (NYSE: ZBH).
- None.
- Clinical trial results and long-term effectiveness data still pending
- Full regulatory approvals for autonomous system not yet obtained globally
Insights
Monogram's autonomous knee replacement surgery milestone advances its acquisition value for Zimmer Biomet while validating its revolutionary robotic technology.
Monogram Technologies has achieved a groundbreaking milestone with the world's first fully autonomous saw-based robotic knee replacement surgery on a live patient. This watershed moment demonstrates that the company's mB么s TKA System can execute precise surgical plans with minimal human intervention 鈥� a quantum leap beyond existing semi-autonomous systems that require continuous surgeon control.
The procedure's success in India, part of a 102-patient clinical trial across multiple centers, validates the safety and effectiveness of Monogram's technology. What's particularly significant is that this comes shortly after the FDA granted 510(k) clearance for Monogram's semi-autonomous TKA System in the US market, creating a clear regulatory pathway.
The timing couldn't be more strategic given Zimmer Biomet's pending acquisition of Monogram. This successful procedure strengthens Zimmer Biomet's position in the
The partnership with Shalby Limited, one of the world's largest orthopedic hospital groups, provides an ideal clinical validation platform with high-volume surgical centers. What separates this technology from existing systems is the autonomous execution of the complex bone-cutting procedure 鈥� the most technically challenging and highest-risk portion of knee replacement surgery.
This development positions Monogram's technology to potentially reduce procedure time, improve surgical precision, and standardize outcomes across surgeons with varying experience levels 鈥� addressing the three most critical challenges in joint replacement procedures today.
The Procedure Utilized Monogram鈥檚 mB么s TKA System Performed in India with Shalby Hospitals
Groundbreaking Procedure Delivers the World鈥檚 First Autonomous Saw-Based Robotic TKA Surgery on a Live Patient
AUSTIN, Texas, July 29, 2025 (GLOBE NEWSWIRE) -- Monogram Technologies Inc. (NASDAQ: MGRM) ("Monogram" or the "Company"), an AI-driven robotics company revolutionizing orthopedic surgery, today announced that on Saturday, July 26, 2025, Monogram completed the first ever fully autonomous saw-based robotic knee replacement procedure on a live patient.
The procedure was performed at the Krishna Shalby Hospital in Ahmedabad India, as part of Monogram鈥檚 multi-center clinical trial in India for the Monogram TKA System.
Figure 1: From left to right, Pankajkumar Yadav, Dr. Douglas Unis, Benjamin Sexson, Dr. Vikram Shah, Dr.Jawahar Pachore, Kamran Shamaei, Dr. Jayesh Patil, Aniruddh Nayak
As , Monogram and Shalby partnered to evaluate the safety and effectiveness of the mB么s TKA System with the Consensus CKS implant, which is substantially equivalent to the Monogram mPress implants for regulatory purposes. On April 29, 2025, Monogram obtained regulatory approval from India's Central Drugs Standard Control Organization ("CDSCO") to import its mB么s TKA system to conduct a multi-center clinical investigation evaluating the safety and effectiveness of the Monogram TKA System. The clinical trial includes 102 total knee replacement procedures, with a three-month clinical follow-up, conducted across multiple sites in India.
鈥淭he first fully autonomous knee replacement on a live patient using Monogram鈥檚 TKA System is a tremendous milestone for the Company. The procedure marks the culmination of years of hard work and dedication by our incredible team. I feel honored and proud to work with such incredible and dedicated individuals at Monogram. The system appears to have flawlessly executed the plan based on intraoperative surgeon evaluation, including intraoperative laxity estimation and achievement of planned alignment. I believe Monogram鈥檚 product will have a significant positive impact on the standard of care for orthopedic medicine in the years to come,鈥� said Benjamin Sexson, CEO of Monogram Technologies.
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鈥淲atching the ease with which the system cut and executed the procedure was incredibly fulfilling. The safety and accuracy of the system were on obvious display. It really was an amazing moment watching Dr. Patil realize that robots can be more than marketing gimmicks but tools that actually change how knee replacements can be done better, said founder Dr. Douglas Unis. 鈥淏ased on years of evaluating technology, watching this surgery was the final validation I needed to know with certainty that we have a groundbreaking product. It was incredible that there was so little stress, given the level of autonomy and first-time use on a living person. It was flawless.鈥�
Figure 2: Post-operative x-ray. Intra-operative stressed laxity and limb alignment, and post-operative stressed laxities and limb alignment were assessed.
鈥淥bserving the flawless execution of this surgical plan was a highlight of my career and incredibly fulfilling. Patient safety has been painstakingly considered in virtually every aspect of our system. Our goal is to have the most efficient, most accurate and safest robot in the world. I am incredibly proud of the hard work of our team and to have had the opportunity to help build this technology,鈥� said Kamran Shamaei, Chief Technical Officer.
鈥淚 feel proud to have played a part in the development of the Monogram TKA System and to have been a member of this incredible team,鈥� said Ani Nayak, Sr. Manager of Clinical R&D. 鈥淎s the individual responsible for the execution of this trial I feel a huge weight of responsibility. To see the system do its job with such low stress and execute the surgical plan as it did was extremely exciting. I believe our product will have a significant clinical impact globally.鈥�
Strategic partner Shalby Limited (NSE: SHALBY) ("Shalby"), one of the world's largest orthopedic hospital groups, will support the 102-patient clinical investigation evaluating the safety and effectiveness of the Monogram TKA System, one of the world's first saw-based autonomous robots.
鈥淚 founded Shalby Hospitals to be a world-renowned center of excellence and innovation for joint replacement surgeries,鈥� said Dr. Vikram Shah, founder of Shalby Hospitals. 鈥淢y vision has always been to pioneer advanced technologies in the field of orthopedic medicine. Having performed thousands of surgeries, I was deeply impressed by what the Monogram team has accomplished and by what was achieved in this surgery, and I look forward to supporting the introduction of this state-of-the-art robotic system, which reaffirms Shalby鈥檚 commitment to leading innovation and excellence in joint replacement surgeries.鈥�
The U.S. Food and Drug Administration (FDA) for Monogram鈥檚 mB么s semi-autonomous TKA System.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, and Monogram Technologies Inc. they entered into a definitive agreement for Zimmer Biomet to acquire all outstanding shares of stock of Monogram.
About Monogram Technologies Inc.
Monogram Technologies (NASDAQ: MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.
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Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the Company's filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.
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FAQ
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