What Mighty Oak Medical does

Mighty Oak Medical is a commercial-stage medical device company founded in 2011 and headquartered in Englewood, Colorado, that develops patient-specific 3D-printed surgical navigation solutions for complex spinal surgery. Its portfolio centers on three integrated products: FIREFLY® Navigation Guides (custom 3D-printed drill guides for cervical, thoracolumbar, and pelvic instrumentation), Acorn 3D (an AI-driven pre-surgical planning platform that automates DICOM scan segmentation, trajectory planning, and spinal alignment analytics), and Anatomical Bone Models (biocompatible, autoclavable 3D-printed reference models). All components are designed as a single workflow from CT scan to intraoperative guide, with manufacturing performed in-house at the Denver Metro Area facility using HP Multi Jet Fusion technology under a 2023 partnership that positions Mighty Oak as HP's Center of Excellence for medical devices.

The company sells through a hybrid GTM model: enterprise field sales directly to spine surgeons at ASCs and hospitals, paired with concierge pre-surgical planning support bundled into each guide order, and an exclusive distribution partnership with OrthoPediatrics (since August 2017) that covers US children's hospitals for pediatric deformity and scoliosis. Pricing is quote-based and varies by case complexity, number of instrumented levels, screw types, and geography; multi-year contracts are noted. Reported operational scale includes 3,700+ completed cases, 80,000+ screws planned, 9 FDA 510(k) clearances, 100+ patents granted worldwide, and multiple Spine Technology Awards. The platform holds CE Mark and EU MDR certification, ISO-10993 biocompatibility, and ISO 13485 quality certification, alongside HIPAA, GDPR, and CCPA compliance.

Revenue is generated primarily through one-time device sales per case augmented by software-enabled pre-surgical planning services; no revenue figures, funding rounds, or institutional investors are disclosed. Customer concentration evidence is surgeon-level and distributed across multiple hospital systems, with the OrthoPediatrics channel representing the most material partner-side concentration. The company is privately held, employs 11-50 people, and is led by founder and CMO George Frey, President Heidi Frey, and VP of Quality and Regulatory Mark Wylie.

Name

Mighty Oak Medical

Legal name

Mighty Oak Medical, Inc.

Website

https://mightyoakmedical.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Mighty Oak Medical is a commercial-stage medical device company that designs patient-specific 3D-printed spinal navigation guides and AI-driven pre-surgical planning software, selling directly to spine surgeons at ASCs and hospitals in the United States.

Ownership category

akta.pro rank

Product category

Spinal Surgery Navigation Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industries

Surgical Navigation, Tracking & Intraoperative Guidance (Ortho/Neuro/ENT) (HLAHADAG), Spine (Orthopedic Spine) (HLAKALAE)

Keywords

• Spine surgery navigation
• Patient-specific surgical guides
• 3D printed medical devices
• Pre-surgical planning software
• Spinal deformity correction

Headquarters

HQ city

Englewood

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales (FIREFLY Navigation Guides): Sale of patient-specific 3D-printed navigation guides and anatomical bone models for spinal surgery. Each case includes concierge pre-surgical planning, custom-printed guides, and anatomical models manufactured in-house.
2. Surgical Planning Software Services (Acorn 3D): AI-driven pre-surgical planning platform providing automated segmentation, trajectory planning, and spinal alignment analytics to support deformity correction planning and surgical preparation.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Mighty Oak Medical designs, manufactures, and sells patient-specific 3D-printed FIREFLY Navigation Guides and anatomical bone models for complex cervical, thoracolumbar, and pelvic spinal surgery. Each case pairs concierge pre-surgical planning powered by the AI-driven Acorn 3D platform with custom-printed surgical guides manufactured in-house in Englewood, Colorado using HP Multi Jet Fusion technology. The offering is targeted at spine surgeons and pediatric hospitals seeking navigation-grade pedicle screw placement accuracy without dedicated intraoperative navigation systems.

Product overview

Mighty Oak Medical offers a unified portfolio of patient-specific spinal surgery solutions centered on three core products: Acorn 3D (AI-powered pre-surgical planning platform), FIREFLY® Navigation Guides (patient-specific 3D-printed surgical navigation), and Anatomical Bone Models (autoclavable 3D printed reference models). The platform integrates pre-surgical planning with 3D-printed guides and anatomical models to enable safer, more efficient complex spinal surgery. All components are designed to work together as an integrated surgical workflow system, with manufacturing performed in-house in the Denver Metro Area using HP Multi Jet Fusion technology.

Differentiator

Problem solved

Functional benefit

Brands

• Acorn 3D: AI-driven pre-surgical planning platform that generates 3D spinal alignment metrics and plans implant inventory for deformity correction planning and surgical preparation.
• FIREFLY®
• FIREFLY Technology

Products and services

• FIREFLY Navigation Guides Patient-specific 3D-printed surgical navigation guides for cervical, thoracolumbar, and pelvic instrumentation that deliver mechanically constrained pedicle screw placement. Sold to spine surgeons with concierge pre-surgical planning and shipped per case from in-house HP Multi Jet Fusion manufacturing in Englewood, Colorado.
• Acorn 3D Pre-Surgical Planning Software AI-powered pre-surgical planning software that performs automated DICOM scan segmentation, generates hundreds of 3D spinal alignment metrics, and plans pedicle screw trajectories and inventory for spine deformity correction. Provided to spine surgeons bundled with FIREFLY guide orders to support pre-operative case preparation.
• Anatomical Bone Models ISO-10993 biocompatible 3D-printed anatomical models in Grey PA12 (Nylon) used as pre-surgical and intraoperative references for musculoskeletal anatomy. Included with FIREFLY guide orders and available as standalone offerings for spine surgeons and surgical teams.
• Concierge Pre-Surgical Planning Service White-glove pre-surgical planning service for spine surgeons that ingests DICOM scans via a HIPAA-compliant upload portal, applies AI-driven Acorn 3D planning, and produces surgeon-customized screw trajectories and inventory. Delivered alongside every FIREFLY guide order as part of the company's patient-specific surgical workflow.

Quantifiable outcome

• 99.7% accuracy in pedicle screw placement
• +4 more outcomes

Named customers4 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

AI capability3 records

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• HP (Hewlett-Packard)coreTechnology or Integration · 1 January 2023HP and Mighty Oak Medical partnered in 2023 to advance 3D-Printed Healthcare Applications. Mighty Oak implements HP's Multi Jet Fusion (MJF) technology to manufacture FIREFLY Navigation Guides. Mighty Oak serves as HP's Center of Excellence for medical devices in the US. The partnership enables cost-effective manufacturing of patient-specific surgical navigation solutions including anatomical models and surgical guides.
• OrthoPediatricscoreChannel Partner/ Reseller/ Distributor · 1 August 2017Since August 2017, OrthoPediatrics has been the exclusive distributor of Mighty Oak Medical's FIREFLY Technology in children's hospitals across the United States. The partnership is based on a shared mission to help children experiencing medical challenges and improve surgical outcomes for pediatric spine surgery patients through adoption of FIREFLY Technology by OrthoPediatrics' network of pediatric spine surgeons.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Medtronic (Mazor / StealthStation): Operates the dominant spinal robotics and surgical navigation franchises (Mazor X, StealthStation) — directly competing with FIREFLY in pedicle screw navigation but with a capital-sale, reusable model serving similar complex-spine surgeons.
• Globus Medical (ExcelsiusGPS): Spine-focused medtech OEM selling ExcelsiusGPS robotic navigation platform — same target surgeon (complex spine deformity), overlapping value proposition around accuracy and radiation reduction, but capital model.
• Stryker (Spine / Navigation): Broad orthopedic and spine franchise with Q Guidance / SpineMask navigation — competes head-to-head for spine OR placement with stronger capital salesforce and hospital contracts.
• Brainlab: Specialized surgical navigation and software platform (Curve, Kick) used across spine and neurosurgery — overlapping technology stack (pre-surgical planning + intraoperative navigation) and shares many of the same complex-spine surgeon customers.
• NuVasive (Pulse / LessRay): Major spine OEM whose Pulse integrated navigation platform and LessRay radiation-reduction technology compete in the same complex-deformity segment with both capital and disposable offerings.

Direct peers

• 7D Surgical: Direct competitor in radiation-free spinal navigation with machine-vision registration. Closely comparable mission (eliminate intraoperative radiation and dedicated techs) and similar mid-cap commercial-stage footprint.
• OrthoPediatrics: Exclusive US children's-hospital distributor for FIREFLY and a direct participant in the pediatric spine segment where Mighty Oak sells — comparable customer base and overlapping product footprint.

Emerging players

• Carlsmed: Patient-specific, 3D-printed spine surgical solutions (aprevo) with AI-driven planning — closest conceptual analog (custom-printed spine devices + planning software), competing for similar hospital attention.
• Materialise (OrthoView / Spine): Additively manufactured patient-specific surgical guides and pre-op planning software across orthopedics/spine — shares the custom-guide-plus-planning software playbook and 3D-printing manufacturing DNA.
• Onkos Surgical: Patient-specific 3D-printed surgical solutions for musculoskeletal oncology and complex orthopedics — adjacent business model (3D-printed patient-specific implants/guides) with planning software integration.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/watch?v=hVA9-C8iBWI
• Xx.com/mightyoakmed
• Facebookfacebook.com/mightyoakmedical
• LinkedInlinkedin.com/company/mighty-oak-medical

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors1 record

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 Mighty Oak Medical