OrthoPlanner
A web-based preoperative planning tool for orthopaedic trauma. Surgeons upload a CT scan and receive a personalised 3D fracture plan prepared by trained staff, covering reduction, implant choice and screw trajectories. CE-marked Class IIa and FDA cleared.
What is OrthoPlanner?
OrthoPlanner is the preoperative fracture planning product of CustomSurg AG, a Zurich company that presents itself as a Harvard and ETH Zurich deep tech venture and was co-founded by a trauma surgeon, a biomedical engineer and a serial entrepreneur. The premise is simple: complex fractures are hard to read from flat two-dimensional imaging, and the resulting ambiguity is carried into theatre. OrthoPlanner takes a CT scan and returns a personalised three-dimensional plan covering the reduction sequence, the implant selection and the screw trajectories, reviewed before the surgeon scrubs in.
It is a regulated medical device, not a consumer app. The product carries a CE mark under the EU Medical Device Regulation as a Class IIa device, certified by notified body TUV SUD Danmark, and the company also claims FDA clearance and an FDA Breakthrough Device designation. A thirty-page instructions for use document is published openly on the site, and it is far more informative than the marketing pages.
That document also corrects a common misreading. OrthoPlanner is not a push-button engine that runs unattended: planning outputs are produced by trained CustomSurg personnel operating the software, and the vendor asks for a minimum of four days per case. The software performs no autonomous diagnosis, selects no implant on its own, and issues no treatment decision. Everything must be reviewed and approved by a surgeon before it is used. Notably, the company never describes the product as artificial intelligence, preferring language around segmentation and finite element analysis.
Three capabilities are highlighted: the core planning view, a Fluoro Vision mode that renders the plan the way it will appear under fluoroscopy and allows comparison with post-operative films, and a 360 view for inspecting articular involvement from any angle. Access is through a browser, with no installation and no hardware. The public site documents tibial plateau, distal femur and pelvis fractures, while the instructions for use list a wider set including proximal and distal tibia, malleoli, acetabulum and distal radius. The company advertises use at more than twenty-five clinical sites and over five hundred planned surgeries, alongside outcome figures of a thirty-two percent reduction in operating time and ninety-six percent fixation accuracy.
What it does
- Turn a patient CT scan into a personalised 3D surgical plan for a fracture
- Set the reduction sequence, implant selection and screw trajectories before entering theatre
- Rotate and inspect the fracture from any angle on a phone or a computer
- Render the plan to match fluoroscopy output and compare it with post-operative X-rays
- Send cases through a personalised upload portal or a standard hospital API
- Request changes to a plan and have them reworked by the vendor's team
- Export the visualised plan as a PDF for the operating room
When to use OrthoPlanner / When not to
A quick filter to help you decide if OrthoPlanner is the right fit.
When to use OrthoPlanner
- Orthopaedic trauma surgeons preparing complex articular fractures of the tibial plateau, distal femur or pelvis
- Operating-room teams that want the reduction sequence and implant strategy settled before the incision
- Radiographers and imaging departments supplying the thin-slice CT studies the plan is built from
- Hospital clinical informatics staff evaluating a browser-based medical device that needs no local install
- Quality and OR-efficiency leads chasing shorter theatre time and more consistent fixation
When not to use OrthoPlanner
- Emergency and on-call teams: the vendor asks for at least four days to prepare a plan, and the device is explicitly not indicated for emergency procedures
- Anyone looking for a diagnostic tool, since the software performs no diagnostic evaluation
- Paediatric practice, where the manufacturer states that no clinical data are available
- Departments without access to a CT scan meeting the required resolution, as X-rays alone will not do
- Non-surgeons: use is restricted to qualified surgeons, so trainees, students and patients are out of scope
How to use OrthoPlanner
A typical end-to-end flow, from setup to results.
- Contact the company through the website, since there is no self-service sign-up
- Go through onboarding, where the vendor collects your name, email address and phone number
- Set your preferences, including a default implant manufacturer and, if useful, a colour palette suited to colour vision deficiency
- Receive a personalised upload link that is yours alone and should not be shared
- Acquire a CT scan meeting the stated limits: slice thickness no greater than 3 mm and in-plane pixel spacing no greater than 1 mm
- Upload the de-identified study from a 64-bit Windows or macOS computer, or send it through a standard hospital API; the upload module does not work on phones
- Allow at least four days for the plan to be prepared by the vendor's trained staff
- Open the visualisation link on a computer or a recent high-end phone or tablet, in a browser supporting WebGL2
- Review the plan, inspect it in 360 view and compare it against fluoroscopy rendering
- Email support with the case identifier if you want the plan reworked, then approve it before surgery
Pros & Cons
Pros
- Genuinely certified as a medical device: CE marked Class IIa under the EU MDR, with the notified body certificate downloadable from the site
- A complete thirty-page instructions for use is published openly, covering contraindications, prerequisites, residual risks and cybersecurity
- No hardware and no installation; the visualisation runs in a browser, including on a phone
- Surgeon review is built into the workflow as a stated requirement rather than an afterthought
- Clinical claims are attached to named institutions and to peer-reviewed publications with direct links
- Testimonials come from identifiable department heads at named hospitals rather than anonymous quotes
- Support response is committed to two to three business days, and plan changes can be requested by email
Cons
- No pricing is published at all: no page, no figure, no range, so any budget conversation starts from zero
- There are no terms and conditions on the site; the imprint links to them through a dead anchor
- The privacy policy is an unfilled template, with most sections left as bracketed instructions to the authors
- The vendor's own documentation states that the personalised upload and visualisation links require no authentication
- A minimum of four days per case, and an explicit exclusion of emergency surgery, rule out a large share of trauma work
- The headline outcome figures are presented without a source study or a denominator, and the claimed 510(k) clearance is called verifiable without a number being given
- No hosting location, no retention period and no data processing agreement are published, which is a lot of silence for software handling medical imaging
Pricing & Plans
No price is published. The site carries no pricing page, no figure and no currency, and the same is true of the product documentation. Commercial access runs entirely through a demo request or a contact form, which points to a quotation-based, contact-sales model. No permanent free plan and no free trial are advertised. Prospective buyers should expect the cost to depend on institution, volume and territory, and should ask for it directly.
Data, GDPR & hosting
A consolidated view of how OrthoPlanner handles your data.
GDPR overview
Every page footer carries the claim HIPAA/GDPR Compliant, repeated on the product and contact pages. The documentation behind that claim is largely missing. The imprint does name a data controller and grants the usual rights of access, rectification, erasure, restriction and objection through info@customsurg.com, and mentions a right to complain to a data protection authority without naming one. But the privacy policy itself is published as an unfilled template: legal basis, purposes, sharing and transfers, retention and rights are all bracketed instructions to the site's own authors rather than actual policy. No data protection officer is designated, and no Article 27 representative is named, which matters because the publisher is established in Switzerland, outside the EU. The compliance claim is therefore asserted but not evidenced.
Who owns the data?
The imprint names CustomSurg AG, at its ETH Zurich address, as the data controller, and points data subjects to info@customsurg.com for access, rectification, erasure or restriction. Beyond that, the published record is thin: the privacy policy on the site is an unfilled template, and the section that should identify the controller and set out data ownership is still a bracketed placeholder. The instructions for use confirm that names, email addresses, phone numbers and stated preferences are stored by the vendor, and that uploaded imaging should be de-identified wherever possible. No clause states who owns the surgical plans produced, and no terms of service exist on the site to settle it.
Reuse rights
There are no published terms of service, so no reuse rights are granted or withheld in writing. What the vendor does document is narrow and one-directional: contact details and preferences are kept to run the service, and source IP address, operating system and browser version are logged solely to track potential cybersecurity threats. Imaging is handled by trained CustomSurg staff to generate the plan. The surgeon receives a 3D visualisation and a PDF of the plan, which the manufacturer insists must be read alongside clinical judgement rather than relied on alone. Nothing on the site addresses whether customer data feeds model development, and the privacy section covering sharing and transfers is an empty placeholder.
Data retention & training
Hosting summary
No hosting location is published. Neither the website, the imprint, the privacy policy nor the instructions for use names a country, a region or a cloud provider for the storage of uploaded imaging or generated plans. What the manufacturer does state is that all data in transit and at rest are encrypted, that the upload and visualisation interfaces are reachable only over HTTPS on port 443, and that source IP address, operating system and browser version are logged purely to track cybersecurity threats. The publisher is established in Switzerland, which sits outside the European Union, and the privacy policy section that should cover processors and transfers outside the EEA is an unfilled placeholder. The marketing site itself is served through a content delivery network, but that says nothing about where clinical data lives. Any hospital should treat hosting jurisdiction as an open question and put it in writing before sending a single study.
Things to keep in mind
Risks and trade-offs to weigh before adopting OrthoPlanner.
- The upload and visualisation links require no authentication by the vendor's own admission: anyone holding the URL can open the case, so link handling becomes a clinical governance problem
- The published privacy policy is an unfilled template while every page claims GDPR compliance, so there is no written commitment on legal basis, transfers or retention to hold anyone to
- The policies section of the imprint describes a different website entirely, citing Wix, HubSpot and Squarespace as its hosting platform: treat none of it as a statement about this service
- No hosting country and no retention period are published for a system that processes patient imaging, which is exactly the question a hospital data protection officer will ask first
- Headline figures of 32 percent less operating time and 96 percent fixation accuracy carry no source study or denominator, and 510(k) clearance is described as verifiable without a number being given
- Automation bias is the real clinical risk: a polished 3D plan invites confidence, and the manufacturer repeatedly warns that the visualisation is for reference only and that model quality is limited by image quality
- Do not read the partner logos as endorsements of the product's performance; Harvard, ETH Zurich, the hospitals and the investor named on the about page are collaborators, and the regulatory certificates belong to the manufacturer alone
Setup & Integrations
Technical difficulty
Low for the surgeon, moderate for the department. There is nothing to install: onboarding is handled by the vendor, who issues a personalised link, and the plan opens in a browser. The constraints sit upstream. Uploads require a 64-bit Windows or macOS computer and will not run on a phone, and viewing needs a recent browser with WebGL2 support. More importantly, the CT protocol must meet the stated limits of 3 mm slice thickness and 1 mm pixel spacing, so radiology has to be involved before the first case is sent.
Deployment
Supported languages
Behind OrthoPlanner
Fundraising
Social
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
What does OrthoPlanner actually do?
Who is allowed to use it?
Which fractures are covered?
How long does it take to get a plan back?
Can it be used in emergency surgery?
What does it cost?
Does the software make the clinical decision?
What is its regulatory status?
Is there an API or a mobile app?
Who publishes it?
Should you pick OrthoPlanner?
OrthoPlanner is one of the rarer entries in this directory: a properly certified medical device rather than a piece of software claiming clinical usefulness. The CE certificate names CustomSurg AG as manufacturer, the notified body is identified, and a full instructions for use document sits in the open where anyone can read the contraindications before committing. That transparency is worth a great deal, and it is what makes the product credible to a trauma surgeon.
It is also narrower than the marketing suggests. This is a service with people in the loop, not an instant engine: plans are prepared by the vendor's trained staff, a case needs at least four days, and emergency surgery is explicitly out of scope. For elective and semi-elective reconstruction of complex articular fractures that is perfectly workable. For the acute trauma list it is not.
The weak point is not the product but what surrounds it. There is no published price, no terms and conditions, and a privacy policy that has been put online as an unfilled template while every page footer claims GDPR compliance. The vendor's own documentation notes that the personalised upload and visualisation links carry no authentication. Add a dead link in the imprint, a 404 on a page the instructions for use point to, and outcome figures given without a source, and the picture is of a strong clinical proposition wrapped in a website that has not caught up with it.
Worth a demo if you operate on tibial plateau, distal femur or pelvic fractures. Go into the procurement conversation with a written list of questions about hosting, retention, link security and price, because the site will not answer any of them.
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