Medical devices & diagnostics · Surgical planning software
AlgoSurg Inc
A Maharashtra and US company building AI software that turns a patient's CT or X-ray into a 3D surgical plan, sold as licensed technology to implant, robotics and 3D printing companies rather than as a device it markets under its own name.
A plan built from an X-ray, not a CT
Most patient-specific instrumentation for a knee replacement starts with a CT or MRI scan, an added cost and an added dose of radiation. AlgoSurg's pitch is that a calibrated X-ray, run through its XrayTo3D algorithm, can produce a 3D bone model good enough to plan the cuts.
The company calls the resulting cutting guide X3DPSI, built inside its web-based planning tool, Tabplan3D. A surgeon uploads a scanogram, the software reconstructs the femur and tibia in three dimensions, and a 3D-printed guide comes back for placement in the operating room.
In a small prospective study of ten patients at an Indian center, comparing X3DPSI-guided pin placement against conventional instrumentation, the mechanical axis alignment came out closer to target with X3DPSI, a difference reported as statistically significant for the femoral cutting plane and the hip-knee-ankle angle. The paper is explicit that this measured a virtual simulation of the cuts, not the actual bone cuts, and that a larger, later-phase study was still to come.
The gap it is aimed at
Patient-specific instrumentation has been studied for years as a way to improve alignment accuracy in total knee arthroplasty without the added time and expense of computer-assisted surgery or robotics. Most versions still require a preoperative CT or MRI. AlgoSurg's argument, laid out by its founders in the surgical literature, is that an X-ray-based version can get close to the accuracy of a CT-based one at a fraction of the cost and radiation exposure, if the reconstruction algorithm proves accurate.
The company has since generalized the same imaging and planning pipeline into a broader software layer: segmentation of CT or MRI, automatic identification of anatomical landmarks, and generation of a surgical plan, aimed at implant makers, robotic surgery system builders, navigation and AR companies and 3D printing shops who want a branded planning module rather than a fully built one of their own.
Two engineers in Thane
Vikas Karade and Amit Maurya founded the company in Maharashtra. Karade, who holds a PhD and describes himself as having more than ten years in medical software development, AI and machine learning based medical image processing, surgical simulation and robotics, is the listed founder and CEO on AlgoSurg's Y Combinator profile and remains a director of the Indian entity along with Maurya.
Indian corporate records show a first entity, AlgoSurg Products Private Limited, registered in Maharashtra in 2016, followed by AlgoSurg Technologies India Private Limited, incorporated on January 19, 2018 and registered with the Registrar of Companies, Mumbai, with Karade and Maurya as its directors. AlgoSurg went through Y Combinator's Winter 2018 batch the same year, and records.json lists 2018 as the company's founding year.
The company won the American Bazaar Startup Competition in Mumbai in 2017, while it described itself, per a YourStory profile from that period, as building software to simulate orthopaedic surgeries in 3D from existing 2D X-ray images.
From a single product to a licensing platform
By 2025, AlgoSurg's own account of its business had shifted from a single surgical-planning tool to a platform it licenses into other companies' products. Its website lists DeftFix, a cloud planner for hexapod fixators, as licensed to S.H. Pitkar, one of the oldest implant manufacturers in India, with thousands of surgeries said to have used it. A cloud-based TAVR planning tool is licensed to an unnamed "leading global TAVR implant OEM," with trials and an FDA submission described as in process, not completed. A maxillofacial (CMF) planning and 3D-printing tool is in pilot testing with unnamed 3D printing firms.
Karade told the Center for Data Innovation in mid-2025 that the platform builds on an enhanced version of nnU-Net, and that the company is working on real-time AR support to guide surgeons during operations. In a separate interview with 3Druck.com, he described the workflow as three steps, segmentation, planning, and CAD design, and said AI has so far made the most progress on the first.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| X3DPSI accuracy study | Prospective, 10-patient study at one Indian center, registered in the Clinical Trials Registry of India (CTRI/2018/09/015818). Reported statistically significant improvement in femoral cutting plane and HKA angle errors versus conventional instrumentation, measured virtually rather than on the actual bone cuts. Published in the Indian Journal of Orthopaedics, 2022. | Public record |
| Earlier reconstruction validation papers | Two related Indian Journal of Orthopaedics papers (2021, 2022) and a 2024 Knee paper on axial alignment and knee phenotypes, all co-authored by Karade or Maurya with orthopedic surgeon Vivek Shetty, testing the underlying X-ray to 3D reconstruction method. | Public record |
| FDA clearance for AlgoSurg products | No 510(k) record found in the FDA database under AlgoSurg, DeftFix, or S.H. Pitkar as applicant, using several name variants. | Not found |
| DeftFix, "FDA-Approved" | AlgoSurg's own product page describes DeftFix as an "FDA-Approved Cloud Planner for Hexapod Fixators." No matching 510(k) clearance for DeftFix, S.H. Pitkar, or a hexapod fixator planner tied to either name turned up in the FDA's public database. | Differs from record |
| TAVR planning software | Described by the company as licensed to an unnamed TAVR implant OEM, with "trials followed by US-FDA submission in process," meaning not yet submitted as of the company's own description. | Company-stated |
| Regulatory readiness claim | The company's technology page says its development follows IEC 62304 and ISO 14971 practices and that documentation is "available for regulatory submissions (US-FDA)," language describing preparedness rather than a completed submission. | Company-stated |
| Scale claims: 15,000+ surgeries, 500+ surgeons, 200+ robots | Stated on AlgoSurg's own website with no named customers, case list or third-party audit found to confirm the figures. | Company-stated |
| Indian corporate registration | AlgoSurg Technologies India Private Limited, CIN U72900MH2018FTC304507, incorporated Jan 19, 2018, registered at the Registrar of Companies, Mumbai, directors Vikas Karade and Amit Maurya, status Active. A predecessor entity, AlgoSurg Products Private Limited, was registered in Maharashtra in 2016. | Public record |
| US SEC filings | No Form D or other filing found in SEC EDGAR under any AlgoSurg name search. | Not found |
| CDSCO registration in India | No CDSCO listing tying AlgoSurg's software or its licensed products to a device registration was found in this research. | Not found |
Read plainly: what is independently documented is AlgoSurg's underlying research, three peer-reviewed papers on X-ray-to-3D reconstruction and a small clinical pilot with a virtual-cuts endpoint, done years before its current pitch as a white-label planning platform. The commercial claims, licensing deals, deployment counts and at least one regulatory claim about DeftFix rest on the company's own statements and were not corroborated in FDA, SEC or CDSCO public records found here.
What to watch
- Whether AlgoSurg or its named partners file for FDA clearance, and whether a new listing appears under either name.
- A larger-phase clinical study of X3DPSI measuring actual postoperative outcomes, since the published pilot measured simulated cuts on ten patients.
- Named customers or an independent case count, rather than the company's own "15,000+ surgeries" figure.
- Any SEC Form D or other capital-raise filing, none of which currently exists for AlgoSurg.
In their words
“AlgoSurg is addressing major challenges in surgical planning, including delays, inefficiencies, and the variability of manual processes.”
Vikas Karade, founder and CEO, Center for Data Innovation interview, July 2025 · Interview
“We’re also developing real-time AR support to guide surgeons directly during operations.”
Vikas Karade, Center for Data Innovation interview, July 2025 · Interview
“Most of AlgoSurg’s AI and imaging work today focuses on robot-assisted surgery and surgical planning.”
Vikas Karade, 3Druck.com interview, 2026 · Interview
“AI already automates segmentation today. In the near future, it can support designers with CAD copilots and enable generative design workflows in the long term.”
Vikas Karade, 3Druck.com interview, 2026 · Interview
“The mechanical axis alignment achieved based on the virtual cuts made using the X3DPSI® was significantly better than the alignment achieved based on the cuts made using the CI, in terms of both HKA and MAD.”
Shetty, Shekhar, Karade, Maurya, Sankar and Wagh, Indian Journal of Orthopaedics, 2022 · Public record
“To overcome the challenges posed by these CT/MRI-based PSIs, AlgoSurg Inc. suggested a novel X-ray-based method to design PSI (X3DPSI®) which in theory seemed to be practical in all respects.”
Same paper, Indian Journal of Orthopaedics, 2022 · Public record
“AlgoSurg technology is already licensed by leading MedTech OEMs in robotic surgery systems and trauma fixator planners, as well as upcoming cardiovascular and maxillofacial workflows.”
AlgoSurg products page, accessed September 2026 · Company-stated
Related companies
Sources
- Public recordA Study of Surgical Accuracy with X-Ray-Based Patient-Specific Instrument (X3DPSI) vs Conventional Instrument in Total Knee Arthroplasty Surgeries
- Public recordCT-Based 3D Reconstruction of Lower Limb Versus X-Ray-Based 3D Reconstruction
- Public recordEvaluating axial alignment and knee phenotypes in a young Indian population
- Public recordFDA 510(k) database search, applicant AlgoSurg, S.H. Pitkar and name variants
- Public recordSEC EDGAR company search, AlgoSurg, Form D
- Public recordALGOSURG TECHNOLOGIES INDIA PRIVATE LIMITED, legal entity record, CIN U72900MH2018FTC304507
- Public recordALGOSURG PRODUCTS PRIVATE LIMITED, legal entity record, CIN U33110MH2016PTC273035
- Interview5 Questions with Dr. Vikas Karade, CEO AlgoSurg
- InterviewInterview with Vikas Karade from AlgoSurg: From CT Data to 3D Printing, how AI automates medical workflows
- IndependentAlgoSurg Company Profile Funding & Investors
- IndependentAlgoSurg Founder Genealogy
- CompanyAlgoSurg Inc: We make AI technology for Robotic and AR Surgeries
- CompanyAlgoSurg homepage
- CompanyTechnologies page
- CompanyProducts (Use Cases) page, DeftFix and TAVR planning descriptions
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
