Orthokey

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.

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

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 industry

PRIMARYHLAHADAF

Surgical Robotics & Computer-Assisted Surgery Platforms

Healthcare & Life Sciences/Medical Devices & Diagnostics/Surgical Instruments, Endoscopy & OR Equipment

SECONDARYHLAHAEAL

Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine)

Healthcare & Life Sciences/Medical Devices & Diagnostics/Implants & Prosthetics (Orthopedic/Neuro/Spine/Dental)

Keywords

• Computer-assisted orthopedic surgery
• Surgical navigation systems
• Robotic knee surgery
• Orthopedic medical devices
• Surgical consumables

Headquarters

HQ city

Firenze

HQ country

Italy

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. 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.
2. 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.
3. 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.
4. 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

Core 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

Named customers19 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration12 records

AI capability4 records

Feature6 records

Partnerships

30 partnerships are on record, tiered core and minor.

• Adler OrthocoreChannel Partner/ Reseller/ DistributorItalian orthopedic implant manufacturer and commercial partner distributing Orthokey navigation technologies alongside its own implant products.
• Amplitude SurgicalcoreChannel Partner/ Reseller/ DistributorFrench orthopedic implant company and long-term commercial partner of Orthokey. Collaboration spans multiple years of joint commercial activities.
• CeravercoreChannel Partner/ Reseller/ DistributorOrthopedic implant manufacturer serving as commercial partner for Orthokey navigation systems.
• LINK (Waldemar LINK GmbH & Co. KG)coreChannel Partner/ Reseller/ DistributorGerman orthopedic implant company and commercial partner distributing Orthokey navigation technology in Germany and internationally.
• DePuy Synthes (Johnson & Johnson)coreChannel Partner/ Reseller/ DistributorMajor global orthopedic company with historical collaboration with Orthokey on joint commercial activities and implant integration.
• Mathys AGcoreChannel Partner/ Reseller/ DistributorSwiss orthopedic implant company partnering with Orthokey for navigation-compatible prosthetic solutions.
• Zimmer BiometcoreChannel Partner/ Reseller/ DistributorGlobal orthopedic company with documented historical collaboration with Orthokey on joint commercial projects.
• United OrthopediccoreChannel Partner/ Reseller/ DistributorTaiwan-based orthopedic implant company serving as commercial partner for Orthokey in Asia-Pacific markets.
• Istituto Ortopedico Rizzoli (Bologna, Italy)coreStrategic or Co-development PartnerLeading 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'InformazionecoreStrategic or Co-development PartnerUniversity department collaborating on ARTS4.0 augmented reality surgery project and other research initiatives involving Orthokey navigation technology.
• Fondazione Don Carlo Gnocchi - ONLUSminorStrategic or Co-development PartnerHealthcare foundation collaborating with Orthokey on WELLNESS@WORK project for workplace stress monitoring using wearable sensor technology.
• Fondazione Stella MarisminorStrategic or Co-development PartnerPediatric research institute collaborating on DI-ASD project for autism spectrum disorder diagnosis support technology.
• University of BolognaminorStrategic or Co-development PartnerAcademic partner in DI-ASD and other research projects involving Orthokey software and technology development.
• Humanitas Research HospitalminorStrategic or Co-development PartnerItalian research hospital collaborating on healthcare technology research projects with Orthokey.
• Isokinetic Medical GroupminorStrategic or Co-development PartnerSports medicine and rehabilitation group collaborating on orthopedic research projects.
• Cresco Lab SrlsminorStrategic or Co-development PartnerResearch company collaborating on ARTS4.0 augmented reality surgery project with Orthokey.
• Ma.Vi. S.r.l.minorStrategic or Co-development PartnerCompany collaborating on ARTS4.0 augmented reality tumor surgery project alongside Orthokey.
• MEDEA (Malattie Degenerative Articolari) Project ConsortiumminorStrategic or Co-development PartnerResearch consortium focused on degenerative joint diseases, collaborating with Orthokey on ETHEREAL and related healthcare projects.
• University College Cork (Ireland)minorStrategic or Co-development PartnerAcademic partner in ETHEREAL Horizon Europe project addressing mental health in adolescents with autism.
• University of Southampton (UK)minorStrategic or Co-development PartnerAcademic partner in ETHEREAL project focusing on mental health disorder prevention in adolescents with ASD.
• Warsaw University of Technology (Poland)minorStrategic or Co-development PartnerTechnical university partner in CARE UP active and assisted living project.
• Carol Davila University of Medicine and Pharmacy (Romania)minorStrategic or Co-development PartnerMedical university partner in ETHEREAL project addressing mental health disorders in adolescents with autism spectrum disorder.
• Microlink PC (UK)minorStrategic or Co-development PartnerTechnology company collaborating on ETHEREAL project for mental health technology solutions.
• Eclexys Sagl (Switzerland)minorStrategic or Co-development PartnerSwiss company collaborating on CARE UP active and assisted living project with Orthokey.
• Saphyrion Sagl (Switzerland)minorStrategic or Co-development PartnerSwiss ICT company collaborating on CARE UP project for elderly care monitoring platforms.
• EURAG Österreich (Austria)minorStrategic or Co-development PartnerEuropean older persons organization partner in CARE UP project for active and assisted living solutions.
• Smartex S.r.l.minorStrategic or Co-development PartnerWearable technology company collaborating on WELLNESS@WORK project for workplace stress monitoring with smart garments.
• Shinteck S.r.l.minorStrategic or Co-development PartnerTechnology company collaborating on WELLNESS@WORK project for workplace stress monitoring solutions.
• Signo Motus S.r.l.minorStrategic or Co-development PartnerCompany collaborating on DI-ASD autism spectrum disorder diagnosis support project.
• Mathema S.r.l.minorStrategic or Co-development PartnerCompany collaborating on DI-ASD project for technology-supported ASD diagnosis.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct 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

• Xtwitter.com/orthokey
• YouTubeyoutube.com/@orthokeyitalias.r.l.9780
• Facebookfacebook.com/Orthokeysurgery
• LinkedInlinkedin.com/company/orthokey

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Orthokey