Orthokey
Orthokey is a Florence-based medical device company developing computer-assisted navigation systems (BLU-IGS), an open-platform orthopedic robot (ROBIN), gyroscopic cutting guides (PERSEUS), and ACL sensors (KiRA) for hospitals and orthopedic surgeons across Europe, the Americas, and Asia-Pacific.
- Company typePrivate
- Founded2005
- HeadquartersCarrara, Italy
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Orthokey does
Orthokey Italia S.r.l. is a Florence, Italy-based private medical device company founded in 2005 that develops computer-assisted surgical platforms and smart digital instruments for orthopedic applications. The company's product portfolio centers on lower-limb surgery and is structured as a platform-plus-modules architecture: BLU-IGS serves as the core infrared-based navigation system for total knee arthroplasty (TKA), unicompartmental knee arthroplasty, total hip arthroplasty, revision TKA, and high tibial osteotomy; ROBIN is the open-platform robotic platform built on BLU-IGS infrastructure, available in Light (navigation-only) and Compact (navigation + robotics) versions, holding the distinction of being the only European-made TKA robot; PERSEUS is a gyroscope-based extramedullary cutting guide that delivers navigation-level accuracy without intramedullary rods; and KiRA is an iPad-connected tri-axial accelerometer sensor for quantitative ACL laxity assessment. Supporting accessories include navigation markers compatible with third-party platforms (Medtronic StealthStation, Aesculap Orthopilot, BrainLAB systems) and sterile drapes for operating room equipment.
The company monetizes through capital equipment sales of BLU-IGS and ROBIN systems, recurring consumables revenue from single-use navigation markers, sterile drapes, and PERSEUS disposable sensors, plus service and support contracts including the ROBIN Care+ 5+ year lifecycle program. Go-to-market combines direct enterprise field sales to hospitals and orthopedic clinics with a channel network of commercial partners (implant manufacturers and distributors including Adler Ortho, Amplitude Surgical, Ceraver, LINK, United Orthopedic, Zimmer Biomet, and DePuy Synthes) across 22 countries. Orthokey holds ISO 13485:2016 certification, CE marking under EU MDR 2017/745 (with ROBIN achieving approval in 2025), and FDA 510(k) clearance for PERSEUS, supporting commercialization in the EU and US. The company reports approximately 4,000 surgeries performed annually using its systems across 12 primary markets and operates with 11-50 employees.
Orthokey firmographics
Firmographics- Name
- Orthokey
- Legal name
- Orthokey Italia S.r.l.
- Website
- https://orthokey.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Orthokey is a Florence-based medical device company developing computer-assisted navigation systems (BLU-IGS), an open-platform orthopedic robot (ROBIN), gyroscopic cutting guides (PERSEUS), and ACL sensors (KiRA) for hospitals and orthopedic surgeons across Europe, the Americas, and Asia-Pacific.
- Ownership category
- akta.pro rank
Orthokey industry classification
Industry- Product category
- Surgical Navigation and Robotics
- NAICS
- Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Surgical Robotics & Computer-Assisted Surgery Platforms (HLAHADAF)
- akta.pro secondary industry
- Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine) (HLAHAEAL)
Keywords
Where Orthokey is headquartered
LocationHeadquarters
- HQ city
- Carrara
- HQ country
- Italy
- HQ region
- Europe
Offices3 records
Markets served
Orthokey business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure
Revenue model
- Medical Device Hardware Sales: Sale of active medical devices including navigation systems (BLU-IGS/ROBIN), robotic platforms (ROBIN), gyroscopic cutting guides (PERSEUS), and sensors (KiRA). Systems are sold as capital equipment to hospitals, with ROBIN available in Light (navigation-only) and Compact (navigation+robotics) versions.
- Accessories and Consumables: Sale of single-use accessories including navigation markers (Snap, Twist, Quick-Twist), sterile drapes, navigated biopsy needles, pedicle access kits, and PERSEUS disposable sensors. Recurring revenue from consumables used per procedure.
- Service and Support Contracts: Technical support services including remote troubleshooting, on-site field support, preventive maintenance, software updates, and the ROBIN Care+ long-term support program with 5+ year lifecycle coverage. Training and education services including workshops, webinars, demos, and wet-lab sessions.
- Licensing and Co-development with OEM Partners: Collaborative development and licensing arrangements with orthopedic implant companies. Orthokey's open platform navigation and robotic technology is compatible with multiple implant systems, allowing partner companies to integrate Orthokey technology into their offerings.
Go-to-market motion2 records
Distribution channels4 records
Marketing channels10 records
Orthokey product offering
Product offeringCore offering
Orthokey designs, manufactures, and commercializes computer-assisted and robotic orthopedic surgery systems, including navigation platforms (BLU-IGS), robotic platforms (ROBIN), gyroscope-based cutting guides (PERSEUS), and ACL laxity assessment devices (KiRA). The company also supplies consumable accessories such as navigation markers and sterile drapes, along with training, support, and assistance programs for orthopedic surgical teams.
Product overview
Orthokey is a Florence-based medical device company founded in 2005 specializing in computer-assisted and robotic orthopedic surgery solutions. The product portfolio is organized as a platform-plus-modules architecture. The core offerings are BLU-IGS (navigation system) and ROBIN (robotic platform built on BLU-IGS infrastructure, available in Light and Compact versions), which together cover navigation, robotics, and the full range of lower limb arthroplasty procedures. Supporting these are PERSEUS (gyroscope-based cutting guide for TKA) and KiRA (iPad-based ACL laxity assessment sensor). Accessories include Navigation Markers compatible with Medtronic, Aesculap, and BrainLAB navigation systems, and sterile Drapes for OR equipment. Services include the Robin Assistance Program, Help Desk ticketing, Robin Educational Framework training, and STUDYManager study management portal.
Differentiator
Problem solved
Functional benefit
Brands
- BLU-IGS: Navigation System for lower limb - evolved into ROBIN platform
- ROBIN
- PERSEUS
- KiRA
Products and services
- ROBIN Robotic platform for computer-assisted orthopedic knee surgery, designed for orthopedic surgical teams performing arthroplasty, with variants tailored to different clinical workflows.
- BLU-IGS Computer-assisted navigation system for orthopedic surgery, providing image and instrument guidance to support surgical precision in joint procedures.
- PERSEUS Gyroscope-based inertial cutting guide that uses tri-axial accelerometer sensing to assist orthopedic surgeons in achieving accurate bone cuts during joint procedures.
- KiRA Sensor-based device for intra-operative assessment of ACL laxity, intended for orthopedic surgeons performing ligament reconstruction procedures.
- Navigation Markers Consumable markers used in conjunction with Orthokey navigation and robotic systems to enable tracking during computer-assisted orthopedic procedures.
- Drapes Sterile surgical drapes designed for use with Orthokey navigation and robotic platforms, intended for use by surgical teams in the operating room.
Quantifiable outcome
- 4,000 surgeries per year performed using Orthokey systems
- +5 more outcomes
Companies that use Orthokey
Customer profileNamed customers19 records
Segments3 records
Ideal customer profiles2 records
Orthokey technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration12 records
AI capability4 records
Feature6 records
Orthokey partnerships and signals
Strategic signalPartnerships
30 partnerships are on record, tiered core and minor.
- Adler OrthocoreItalian orthopedic implant manufacturer and commercial partner distributing Orthokey navigation technologies alongside its own implant products.
- Amplitude SurgicalcoreFrench orthopedic implant company and long-term commercial partner of Orthokey. Collaboration spans multiple years of joint commercial activities.
- CeravercoreOrthopedic implant manufacturer serving as commercial partner for Orthokey navigation systems.
- LINK (Waldemar LINK GmbH & Co. KG)coreGerman orthopedic implant company and commercial partner distributing Orthokey navigation technology in Germany and internationally.
- DePuy Synthes (Johnson & Johnson)coreMajor global orthopedic company with historical collaboration with Orthokey on joint commercial activities and implant integration.
- Mathys AGcoreSwiss orthopedic implant company partnering with Orthokey for navigation-compatible prosthetic solutions.
- Zimmer BiometcoreGlobal orthopedic company with documented historical collaboration with Orthokey on joint commercial projects.
- United OrthopediccoreTaiwan-based orthopedic implant company serving as commercial partner for Orthokey in Asia-Pacific markets.
- Istituto Ortopedico Rizzoli (Bologna, Italy)coreLeading Italian orthopedic research institute collaborating with Orthokey on R&D, clinical validation, and product development for navigation and robotic surgery systems.
- Università di Pisa - Dipartimento di Ingegneria dell'InformazionecoreUniversity department collaborating on ARTS4.0 augmented reality surgery project and other research initiatives involving Orthokey navigation technology.
- Fondazione Don Carlo Gnocchi - ONLUSminorHealthcare foundation collaborating with Orthokey on WELLNESS@WORK project for workplace stress monitoring using wearable sensor technology.
- Fondazione Stella MarisminorPediatric research institute collaborating on DI-ASD project for autism spectrum disorder diagnosis support technology.
- University of BolognaminorAcademic partner in DI-ASD and other research projects involving Orthokey software and technology development.
- Humanitas Research HospitalminorItalian research hospital collaborating on healthcare technology research projects with Orthokey.
- Isokinetic Medical GroupminorSports medicine and rehabilitation group collaborating on orthopedic research projects.
- Cresco Lab SrlsminorResearch company collaborating on ARTS4.0 augmented reality surgery project with Orthokey.
- Ma.Vi. S.r.l.minorCompany collaborating on ARTS4.0 augmented reality tumor surgery project alongside Orthokey.
- MEDEA (Malattie Degenerative Articolari) Project ConsortiumminorResearch consortium focused on degenerative joint diseases, collaborating with Orthokey on ETHEREAL and related healthcare projects.
- University College Cork (Ireland)minorAcademic partner in ETHEREAL Horizon Europe project addressing mental health in adolescents with autism.
- University of Southampton (UK)minorAcademic partner in ETHEREAL project focusing on mental health disorder prevention in adolescents with ASD.
- Warsaw University of Technology (Poland)minorTechnical university partner in CARE UP active and assisted living project.
- Carol Davila University of Medicine and Pharmacy (Romania)minorMedical university partner in ETHEREAL project addressing mental health disorders in adolescents with autism spectrum disorder.
- Microlink PC (UK)minorTechnology company collaborating on ETHEREAL project for mental health technology solutions.
- Eclexys Sagl (Switzerland)minorSwiss company collaborating on CARE UP active and assisted living project with Orthokey.
- Saphyrion Sagl (Switzerland)minorSwiss ICT company collaborating on CARE UP project for elderly care monitoring platforms.
- EURAG Österreich (Austria)minorEuropean older persons organization partner in CARE UP project for active and assisted living solutions.
- Smartex S.r.l.minorWearable technology company collaborating on WELLNESS@WORK project for workplace stress monitoring with smart garments.
- Shinteck S.r.l.minorTechnology company collaborating on WELLNESS@WORK project for workplace stress monitoring solutions.
- Signo Motus S.r.l.minorCompany collaborating on DI-ASD autism spectrum disorder diagnosis support project.
- Mathema S.r.l.minorCompany collaborating on DI-ASD project for technology-supported ASD diagnosis.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
Orthokey competitors and assessment
Company assessmentDirect peers
- Brainlab: Brainlab offers surgical navigation platforms (VectorVision, Curve, Kick, Kolibri) for multiple specialties. Orthokey's navigation markers are explicitly compatible with Brainlab systems, and both compete in image-guided orthopedic and neurosurgical navigation — making Brainlab the closest direct technology peer.
- OrthAlign: OrthAlign is a US-based, privately-held orthopedic surgical navigation company offering imageless handheld navigation for knee and hip arthroplasty. Its size, focus, and product overlap with Orthokey's PERSEUS and BLU-IGS make it a strong small-cap direct peer.
- THINK Surgical: THINK Surgical develops TMINI and other open-platform TKA robotics — directly comparable to Orthokey's ROBIN open-platform positioning. Both are smaller ortho robotics pure-players targeting the same counter-positioning to Stryker Mako's closed ecosystem.
- Aesculap (B. Braun) OrthoPilot: Aesculap's OrthoPilot is one of the long-standing imageless navigation systems for knee arthroplasty and a direct competitor to BLU-IGS. Orthokey's Snap/Easy-Fit markers integrate with OrthoPilot, indicating overlapping customer accounts where the two compete head-to-head.
- Exactech (ExactechGPS): ExactechGPS is an imageless navigation system for shoulder and knee arthroplasty, comparable in scope and scale to Orthokey's BLU-IGS. Its specialty-focused positioning makes it a relevant direct peer in computer-assisted orthopedic surgery.
Broad incumbents
- Stryker (Mako): Stryker's Mako robotic-arm system is the dominant TKA/THA robotics platform globally, bundled with Stryker's implant franchise. Orthokey positions ROBIN as the open-platform European alternative to Mako, making Stryker the principal broad incumbent competitor in orthopedic surgical robotics.
- Zimmer Biomet (Rosa): Zimmer Biomet's Rosa Knee and Rosa Hip robot is a direct competitor in computer-assisted knee/hip arthroplasty. Importantly, Zimmer Biomet is simultaneously an Orthokey commercial partner, mirroring the same dual partner/competitor dynamic Orthokey maintains with DePuy Synthes.
- Johnson & Johnson (DePuy Synthes / VELYS): J&J's VELYS robotic-assisted solution competes directly in TKA navigation/robotics. DePuy Synthes is also listed as an Orthokey commercial partner, creating the same partner-versus-competitor dynamic and anchoring J&J as a key broad incumbent.
- Smith+Nephew (CORI): Smith+Nephew's CORI handheld robotics platform competes in navigated/robotic knee surgery alongside Mako, Rosa, and VELYS. As a global ortho incumbent with a dedicated robotics franchise, it is a relevant broad-incumbent comparator for Orthokey's positioning.
- Medtronic (StealthStation, O-Arm): Medtronic's StealthStation is a major surgical navigation platform; Orthokey navigation markers explicitly integrate with StealthStation while Orthokey also sells compatible O-Arm drapes. Medtronic's cranial/spine nav footprint makes it both an integration partner and a broad-incumbent competitor in image-guided surgery.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Orthokey social profiles
Digital presenceOrthokey compliance and trust
Trust signalCompliance4 records
Orthokey financial estimates
Financial estimateRevenue estimate
Valuation estimate
Orthokey leadership team
Management profileNumber of profiles
Orthokey funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Orthokey M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Orthokey
What does Orthokey do?
Orthokey designs, manufactures, and commercializes computer-assisted and robotic orthopedic surgery systems, including navigation platforms (BLU-IGS), robotic platforms (ROBIN), gyroscope-based cutting guides (PERSEUS), and ACL laxity assessment devices (KiRA). The company also supplies consumable accessories such as navigation markers and sterile drapes, along with training, support, and assistance programs for orthopedic surgical teams.
Is Orthokey a public or private company?
Orthokey is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Orthokey founded?
Orthokey was founded in 2005. It employs 11 to 50 people.
Where is Orthokey based?
Orthokey is headquartered in Carrara, Italy, in the Europe region.
How does Orthokey make money?
Four revenue lines are on record. Medical Device Hardware Sales are the primary driver. The others are accessories and Consumables, service and Support Contracts and licensing and Co-development with OEM Partners.
Who are Orthokey's main competitors?
Direct peers on record are Brainlab, OrthAlign, THINK Surgical, Aesculap (B. Braun) OrthoPilot and Exactech (ExactechGPS). Broad incumbents are Stryker (Mako), Zimmer Biomet (Rosa), Johnson & Johnson (DePuy Synthes / VELYS), Smith+Nephew (CORI) and Medtronic (StealthStation, O-Arm).
Does Orthokey have an API?
No public API is recorded for Orthokey.
What industry is Orthokey in?
Orthokey's product category is Surgical Navigation and Robotics. Its primary akta.pro industry code is HLAHADAF, Surgical Robotics & Computer-Assisted Surgery Platforms, with a secondary code of HLAHAEAL, Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine). Its NAICS code is 339112 and its SIC code is 3841.