OTS Hip
Regulatory Status Disclosed
Overview
OTS Hip by Ortoma AB is an AI-assisted orthopedic surgical platform designed to support total hip arthroplasty (THA). The system integrates preoperative 3D planning, intraoperative navigation, and postoperative verification into a unified clinical workflow. It is developed for orthopedic surgeons and surgical teams operating in hospital and clinical settings.
The platform consists of two primary software modules that integrate into the standard surgical workflow:
- OTS Hip Plan (OHP): A server-based 3D planning tool that processes patient CT scan data. Using automated AI algorithms, the software performs bone segmentation, identifies anatomical landmarks, and suggests optimal implant sizes and positioning within minutes. Surgeons can then review, fine-tune, and validate the plan.
- OTS Hip Guide (OHG): An intraoperative navigation system that transfers the validated preoperative plan directly to the operating room. It utilizes a passive marker sensor system and a tracked freehand probe to provide real-time tracking of surgical tools, assisting the surgeon in precisely placing the implant relative to the patient’s anatomy.
The system is designed with a small physical footprint to integrate into existing operating room setups with minimal disruption to conventional surgical techniques.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered surgical planning
- 3D preoperative planning based on CT imaging data
- Intraoperative navigation and guidance for implant placement
- Postoperative verification and follow-up
- Optimizes patient outcomes, precision, and efficiency
- Reduces complications and need for follow-up surgeries
- Suggests suitable implant type and size
- Automatic AI analysis for planning (approx. 30 seconds)
- Integrates into existing surgical workflows
- Server-based integrated AI platform
Use Cases
- Preoperative planning for Total Hip Arthroplasty (THA)
- Intraoperative guidance during hip replacement surgery
- Optimizing implant positioning in hip surgery
- Reducing surgical time and improving efficiency in THA
- Post-operative analysis of hip implant placement
- Patient-specific planning for joint replacement
What Physicians Need to Know
Surgical Planning Capabilities
OTS Hip Plan, powered by AI, automates anatomical landmark identification and bone segmentation, generating suitable implants and suggesting positions within seconds. Surgeons can then fine-tune and approve the pre-operative plan, which is available in the operating room within minutes. The system enables surgeons to accurately measure and plan 3D surgery for the placement of joint implants. It also assists in optimizing implant selection and position.
Intraoperative Guidance
OTS Hip Guide is an intraoperative navigation tool that guides surgeons in real-time to place implants in the pre-operatively planned position. It provides precise measurements during navigation to support accurate implant placement. The system aids in surgical precision and can reduce operation duration. The guide tool has demonstrated notable precision in cup placement, mitigating the risk of mispositioning.
3D Reconstruction Quality
The system uses CT medical imaging data for planning orthopedic surgical procedures. Ortoma is also developing a prototype for planning hip surgery based on 2D x-ray images converted into 3D models, aiming to streamline the process and automate planning.
Robotic Surgery Integration
The provided information does not specify direct robotic surgery integration for OTS Hip.
Surgical Navigation Accuracy
The Ortoma Guide system has shown promising accuracy in clinical settings, with measuring precision in surgical positioning better than conventional systems. Studies have confirmed the accuracy of the data presented to the surgeon during surgery with the Hip Guide tool. In patient surgeries, mean errors for cup placement were very low: -0.07 ± 2.72° for anteversion, -0.2 ± 0.86° for inclination, and 0.28 ± 0.78 mm for cup depth.
Pre-Operative Assessment
The OTS Hip Plan software expedites processes and assists surgeons during pre-operative planning. It uses AI to automatically generate information for clinical conclusions, identify landmarks, and suggest suitable implants within seconds. The advanced 3D visualization allows surgeons to adapt to unique cases and anticipate surgical situations.
Post-Operative Monitoring
The software uses AI to analyze surgery results, automatically detecting and verifying implant position. Surgeons can compare multiple scans over time to monitor implant migration or wear. The Follow-up module evaluates migration results from AI-based CT-RSA.
Complication Prediction
Ortoma's surgical system aims to provide better patient outcomes, fewer complications, and less follow-up surgeries, leading to better long-term implant survival rates. The intra-operative guidance helps mitigate the risk of cup mispositioning.
Operating Room Workflow Integration
OTS is designed for easy integration into existing surgical processes and routines, increasing efficiency. The pre-operative plan is instantly available for surgery through seamless integration with OTS Plan. The system allows surgeons to use their own equipment with minor alterations, making the transition comfortable. The OTS unit has a small footprint, facilitating workflow with minimal deviation from technique.
Physician Tip
The OTS Hip system, with its AI-powered planning and real-time navigation, aims to enhance precision and efficiency in total hip replacement surgeries. Surgeons can leverage the rapid CT scan data processing and 3D planning capabilities to optimize implant positioning and potentially reduce operative time. The system's design for seamless integration into existing workflows and compatibility with a surgeon's own equipment may ease adoption. Post-operative monitoring features allow for long-term tracking of implant stability.
Ortoma has a development and distribution agreement with DePuy Synthes (part of Johnson & Johnson MedTech) to integrate DePuy Synthes' technology into a customized OTS for hip replacement surgery. The OTS platform is designed to be easily integrated into hospital systems.
Details
| Category | Surgical AI |
| Pricing | Unknown |
| Deployment | Server-based AI integrated orthopedic platform. |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Unknown |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Orthopedics |
What the Web Says
Ortoma's OTS Hip is an AI-powered surgical platform designed to enhance precision and efficiency in total hip replacement procedures. It includes modules for pre-operative planning, intra-operative navigation, and post-operative follow-up. The system aims to improve patient outcomes by guiding surgeons to optimally position implants and reducing surgical variations.
Overall: PositiveStrengths
- Improved surgical precision and accuracy in implant placement.
- AI-based pre-operative planning automates landmark identification and implant suggestions, saving time.
- Real-time intra-operative navigation guides surgeons to the pre-planned position.
- Potential for reduced operation duration.
- Designed to integrate easily into existing surgical workflows with a small footprint.
- Aims for better patient outcomes, fewer complications, and reduced need for revision surgeries.
Limitations
- One recall was identified for an Ortoma AB product, the Ortoma Inserter Adapter OTD.
- Some sources discuss hip replacement surgery in general, including potential complications and recovery, which are not specific to OTS Hip but are inherent to the procedure.
- The system is currently being rolled out in selected markets and may not be available everywhere.
- While FDA cleared, the specific clearance date for the current iteration (K250086) is listed as May 2025, suggesting it is a relatively new or updated device in the US market.
Based on reviews from: orthoworld.com, hospitals-management.com, medistill.ai, healthaidb.com, researchgate.net, scribd.com, odtmag.com, innolitics.com, cision.com, northwell.edu, medworldadvisors.com, ortoma.com, fda.gov, nasdaq.com, nih.gov, actaorthop.org, beckersspine.com, researchsquare.com, reddit.com
Last updated: 2026-10-31
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Press & Coverage
ortoma.com
Ortoma receives FDA 510 (k) clearance for OTS™ Hip in the US
Ortoma AB announced it received FDA 510(k) clearance for its OTS™ Hip, allowing it to market the AI-powered surgical system in the United States. This clearance is a significant step for commercializing OTS™ Hip in the U.S. market, which is the largest worldwide for orthopedic surgical equipment.
2024-03
odtmag.com
FDA Clears Ortoma AB's OTS Hip System
The U.S. Food and Drug Administration (FDA) has granted a 510(k) clearance to Ortoma AB for its AI-powered OTS Hip system, which includes Hip Plan and Hip Guide for preoperative planning, intraoperative navigation, and postoperative follow-up in hip procedures. This clearance enables Ortoma to commercialize OTS Hip in the U.S. market.
2024-03
ortoma.com
Ortoma receives FDA 510 (k) clearance for OTS™ Hip in the US
Ortoma AB has received FDA 510(k) clearance for its OTS™ Hip, an AI-powered surgical system designed to enhance precision, efficiency, and surgical outcomes in hip procedures. This approval is a crucial milestone for the company's entry into the U.S. market.
2025-02
ortoma.com
Ortoma's OTS™ Hip is launched in Japan
Following a clinical evaluation, Ortoma's AI-assisted OTS™ Hip solution is being launched in Japan through a partnership with Johnson & Johnson K.K., who holds exclusive distribution rights for the Japanese market. This launch signifies the product's ability to meet the high demands of the Japanese market and aims to provide significant benefits for surgeons and patients.
2023-05
prnewswire.com
Ortoma agrees on term sheet for development and distribution of customized version of OTS Hip
Ortoma AB has agreed to a non-binding term sheet with DePuy Synthes for the development and distribution of a customized version of OTS Hip for hip surgery, granting worldwide distribution rights (excluding Japan) for an initial term of 7 years. This collaboration is an important step for Ortoma in broadening its partnership with DePuy Synthes.
2022-12
ortoma.com
Ortoma obtains JP certification for hip implant planning module
Ortoma has obtained certification in Japan for its OTS Hip Plan module, which is used for pre-operative planning of hip replacement surgery. This certification is a crucial step for introducing OTS Hip in Japan.
2021-12
researchgate.net
Evaluation of the Accuracy of an AI-Based Orthopedic Surgical Platform in Patients with Severe Hip Dysplasia Using 3D Bone Models
A study evaluated the accuracy of Ortoma Treatment Solution (OTS), an AI-based orthopedic surgical platform, in patients with severe hip dysplasia using 3D bone models. The study aimed to assess the accuracy of AI-based segmentation by OTS and the precision of navigation matching with 3D bone models.
2025-02
mdpi.com
Synthetic Implant Migration Generation for Accuracy and Precision Evaluation of AI-Based CT-RSA in Total Hip Arthroplasty
This study describes a method for generating synthetic implant migration datasets to evaluate the accuracy and precision of an AI-based CT-RSA tool, OTS™ Hip Follow-up, which uses AI-based segmentation and model-based implant alignment to detect bones and implants automatically. The workflow involves importing baseline CT scans into AI-based segmentation and implant detection algorithms within the OTS Hip Plan module.
2026-05
Frequently Asked Questions
OTS Hip uses AI for automated anatomical landmark identification, bone segmentation, and 3D bone reconstruction. This allows for precise preoperative planning, including suggesting optimal implant types, sizes, and positions, and provides real-time intraoperative navigation to guide surgeons for accurate implant placement.
OTS Hip has received FDA 510(k) clearance in the United States, allowing it to be marketed in the U.S. market. It is also CE Marked, indicating compliance with European Union regulations, and has obtained certification in Japan for its OTS Hip Plan module.
While the OTS Hip system aims to improve accuracy and reduce complications, general limitations of total hip replacement still apply, such as potential for reduced range of motion, occasional clicking, and the need for activity modifications. The OTS Follow-up module is also not FDA approved. Additionally, the system's availability may vary by region due to local regulatory clearances and commercial readiness.
Alternatives to AI-powered systems like OTS Hip include traditional 2D template measurements for preoperative planning. Non-surgical alternatives for hip pain management include lifestyle modifications, physical therapy, medications, and injections. Surgical alternatives to total hip replacement include hip arthroscopy, hip resurfacing, partial hip replacement, hip osteotomy, hip fusion, and resection arthroplasty.
The cost of a total hip replacement in the US can range from approximately $18,000 to $74,000, with an average around $39,000, depending on factors like facility, surgeon, anesthesia, and implant. While specific pricing for the OTS Hip system is not publicly available, AI-powered systems aim to improve surgical precision and reduce complications, which could potentially lead to cost savings by minimizing revisions and improving long-term outcomes.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18