What Waypoint Orthopedics does

Waypoint Orthopedics is a privately held medical device company headquartered in Philadelphia, Pennsylvania, founded in 2020 by spine surgeon Dr. Stephen Banco and Runway Healthcare, LP, a MedTech accelerator fund. The company develops the Waypoint GPS (Guided Pedicle System), a fully disposable, single-use pedicle probe that uses proprietary color-sensing technology to distinguish cancellous from cortical bone in real time, giving surgeons visual feedback on probe location during pedicle screw placement in spinal fixation. The device is FDA 510(k)-cleared for both open and minimally invasive spine surgery and is positioned to reduce ionizing radiation exposure for surgeons, staff, and patients, an industry pain point given that spine surgeons are reported to face 12x the radiation exposure of other subspecialties.

The product works as a drop-in replacement for a standard re-usable pedicle probe, requiring minimal change in surgical technique and no capital equipment, while avoiding the cost and complexity of traditional image-guided navigation. Waypoint monetizes via hardware sales of the single-use probe to hospitals and spine surgeons through a US-focused B2B distribution channel.

Go-to-market is built around an exclusive US distribution agreement with Highridge Medical, a global spine company, signed in April 2026, with US commercial launch planned for later that year. The company has raised approximately $3.9M across multiple small exempt offerings between 2020 and 2023, led by Runway Healthcare, LP's $1.7M seed in September 2021, and remains an early-stage, single-product venture operating with a lean leadership team spanning CEO, CTO, CMO, and quality/regulatory functions.

Name

Waypoint Orthopedics

Legal name

Waypoint Orthopedics, Inc.

Website

https://waypointorthopedics.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

Waypoint Orthopedics develops and commercializes the Waypoint GPS, a single-use disposable pedicle probe with proprietary color-sensing technology that helps spine surgeons avoid cortical breaches and reduce radiation exposure during spinal fixation procedures.

Ownership category

akta.pro rank

Product category

Spinal Surgical Instrumentation

NAICS

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

SIC

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

akta.pro primary industry

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

akta.pro secondary industry

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

Keywords

• Spinal surgery devices
• Pedicle screw guidance
• Orthopedic surgical instruments
• Single-use surgical probes
• Minimally invasive spine surgery

Headquarters

HQ city

Philadelphia

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Waypoint GPS Device Sales: Waypoint Orthopedics generates revenue from the sale of its fully disposable, single-use Waypoint GPS pedicle probe. The device is sold as a hardware product to spine surgeons and hospitals for use during spinal fixation procedures.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Waypoint Orthopedics designs, develops, and sells the Waypoint GPS (Guided Pedicle System), a fully disposable, single-use pedicle probe used by spine surgeons during spinal fixation procedures. The device applies proprietary color-sensing technology to differentiate cancellous from cortical bone in real time, providing visual feedback that helps surgeons avoid cortical breaches and reduce reliance on intraoperative radiation when placing pedicle screws in both open and minimally invasive (MIS) spine surgery. The product is FDA-cleared and sold to hospitals and surgical centers via an exclusive U.S. distribution agreement with Highridge Medical.

Product overview

Waypoint Orthopedics is a single-product medical device company. The company's sole offering is the Waypoint GPS (Guided Pedicle System), a fully disposable, single-use pedicle probe with proprietary color-sensing technology that provides real-time visual feedback during spinal surgery to help physicians avoid cortical breaches and reduce radiation exposure. The product is FDA-approved for use in both open and minimally invasive (MIS) spine surgery.

Differentiator

Problem solved

Functional benefit

Brands

• Waypoint GPS: The Waypoint GPS (Guided Pedicle System) is a fully disposable, single-use pedicle probe that provides physicians with real-time visual feedback of the location of the cutting edge of the probe using proprietary color sensing technology.

Products and services

• Waypoint GPS (Guided Pedicle System) A fully disposable, single-use pedicle probe that uses proprietary color-sensing technology to provide real-time visual feedback distinguishing cancellous from cortical bone during spinal surgery. It is used by spine surgeons during pedicle screw placement in open and minimally invasive (MIS) spinal fixation procedures to avoid cortical breaches and reduce intraoperative radiation exposure. The device is FDA-cleared and intended for hospital and surgical center use.

Quantifiable outcome

• 1.62 million spine surgeries performed annually in the US — all involving some level of radiation exposure.
• +2 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Highridge MedicalcoreChannel Partner/ Reseller/ Distributor · 9 April 2026Highridge Medical entered into an exclusive distribution agreement with Waypoint Orthopedics for the United States to commercialize the Waypoint GPS (Guided Pedicle System). Highridge Medical, a global spine company, plans to launch the product later this year as part of its strategy to double R&D investment through organic development and inorganic technology acquisitions. This is the primary commercial distribution partnership for Waypoint's flagship product.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• 7D Surgical: Developed image-guided spine surgery navigation technology for pedicle screw placement and similar intraoperative guidance workflows, directly competing with Waypoint GPS's intraoperative guidance use case. Acquired by Stryker in 2021, it is the closest analog to Waypoint's niche before integration into a larger portfolio.
• Brainlab: Specialist in surgical navigation, tracking, and intraoperative guidance across orthopedics, neuro, and ENT. Brainlab's spine navigation platform directly overlaps with the intraoperative guidance category in which Waypoint GPS competes.

Broad incumbents

• Medtronic: The largest spine and surgical navigation incumbent, with StealthStation and Mazor robotic platforms targeting pedicle screw placement and broader spinal instrumentation workflows that overlap with Waypoint GPS. Medtronic sets the benchmark scale, evidence base, and capital intensity that Waypoint must compete against.
• Globus Medical: Major spine hardware and navigation/robotics player (now combined with NuVasive) offering ExcelsiusGPS and a broad pedicle screw portfolio. Competes directly with Waypoint GPS in pedicle screw placement workflows across both open and MIS approaches.
• Stryker: Broad MedTech incumbent with spine instrumentation and surgical navigation/robotics (including the acquired 7D Surgical technology) that competes with Waypoint GPS in pedicle screw placement workflows, with far greater resources for clinical data and sales coverage.
• NuVasive (Globus Medical): Major spine company with a comprehensive pedicle screw and minimally invasive surgery portfolio that competes with Waypoint GPS at the implant and instrumentation level adjacent to its guidance use case.
• Johnson & Johnson (DePuy Synthes): Spine and orthopedics incumbent through DePuy Synthes, offering broad pedicle screw systems and navigation solutions that compete in the same spinal fixation workflows as Waypoint GPS.

Emerging players

• Alphatec Spine: Independent spine company focused on degenerative, deformity, and MIS procedures with a growing pedicle screw and instrumentation portfolio. Comparable as a smaller, spine-focused challenger competing for hospital spine business against Waypoint's customer base.
• SI-BONE: Specialized spine company that built a niche surgical franchise (sacroiliac joint fusion) by leveraging focused clinical evidence and a specialist surgeon channel. Comparable as a sub-scale spine company that achieved scale through a clearly defined clinical workflow and surgeon adoption.
• Orthofix Medical: Spine and orthopedics company with pedicle screw, MIS, and motion preservation products that overlap with Waypoint GPS's spine surgical use case. Comparable as a sub-scale incumbent operating in similar hospital purchasing decisions.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/waypoint-orthopedics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds4 records

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 Waypoint Orthopedics