Ortoma Treatment Solution (OTS™)
AI-assisted surgical planning, navigation, and verification platform for orthopedic procedures
Company profile
Company profile
Ortoma AB is a Swedish medical technology company that develops AI-assisted surgical solutions for orthopedic procedures. The company's flagship product, the Ortoma Treatment Solution (OTS™), is a server-based artificial intelligence platform designed to support orthopedic joint and spine surgery. The platform integrates advanced machine learning algorithms to drastically reduce pre-operative planning time, performing automated AI analysis that generates bone segmentation, landmarks, implant size, and implant position suggestions in minutes. Surgeons can then fine-tune and validate plans through an intuitive interface before surgery. The OTS™ platform connects pre-operative planning with precision surgical navigation and post-operative verification, enabling surgeons to control the entire surgical process from planning to follow-up. Ortoma currently focuses on hip arthroplasty and spine surgery, with the goal of improving patient lives by providing surgeons with disruptive surgical technologies that optimize medical outcomes. The company's mission is to provide intuitive, precision cutting-edge solutions to improve outcomes in orthopedic surgeries, enabling surgeons to achieve optimized results for patients, surgeons, and hospitals. Ortoma's products have received regulatory clearances including FDA 510(k) approval, CE marking, and PMDA certification for hip replacement surgery solutions. The company is ISO 13485 certified for its quality management system and maintains compliance with medical device regulations including U.S. 21 CFR820. Ortoma is headquartered in Gothenburg, Sweden, and is publicly traded.
Company description Ortoma AB official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas deployment with recorded integration context.
Company milestones
FDA 510(k) clearance for OTS™ Hip in US (March 2024), UK regulatory registration for OTS™ Hip (March 2026), PMDA certification in Japan, product launch in Japan with Johnson & Johnson K.K. (May 2023), appointed new CEO Fredrik Strömberg (February 2025)
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
AI-assisted surgical planning, navigation, and verification platform for orthopedic procedures
Surgical navigation system for hip replacement procedures
AI-powered pre-operative planning solution for hip arthroplasty
AI-assisted pre-operative planning for spine surgery
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Diagnostics (Basel, Switzerland) · May 14, 2026
Evaluation of migration analysis with AI-based CT-RSA and preoperative 3D-planning in total hip arthroplasty.Acta orthopaedica · Dec 11, 2025
Precision of Cup Positioning Using a Novel Computed Tomography Based Navigation System in Total Hip Arthroplasty.Medicina (Kaunas, Lithuania) · Sep 27, 2024
Comparison between model-based RSA and an AI-based CT-RSA: an accuracy study of 30 patients.Acta orthopaedica · Jan 29, 2024
Clinical validation
No linked records are currently available.
Regulatory
K250086 · 510k · May 16, 2025
OTS HipK232140 · 510k · Mar 11, 2024
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
AI analysis generates surgical plans in minutes versus traditional manual planning
Precision surgical navigation and automated planning
Pre-operative planning instantly available in operating room
Clinical evaluation and launch of OTS™ Hip solution in Japanese market
Development and distribution agreement for customized version of OTS Hip
05 · Leadership
Leadership profiles and professional links from the current Company record.
Fredrik Strömberg
CEO
Dr. Andreas Pettersson
Head of Clinical Operations
Anna Zyla
Head of Operations
Carianne Nilsson
Head of Sales and Marketing
Hassan Nemati
Head of Technical Research
Fredrik Hedberg
Head of QA/RA
Yvonne Mårtensson
Chairman of the Board
Gisli Hennermark
Board Member
06 · Company updates
Recent articles published on Ortoma AB's official website.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Companies developing surgical technologies enhanced by AI, including robotic surgical systems, AI-powered surgical assistance and navigation tools, autonomous surgical robotics, and surgical data and analytics platforms. Covers both the performance of surgery and the analysis of surgical outcomes and OR efficiency.
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