Devices
Stryker Completes First FDA-Authorized Intraoperative Surgery Using Apple Vision Pro
SportSuite Vision's De Novo clearance and a live hip arthroscopy at Duke Health establish the first regulatory pathway for spatial computing in the operating room.
Mainstay Communications Team · · 4 min read
In brief
Stryker's SportSuite Vision received FDA De Novo authorization on July 17, 2026, becoming the first application cleared for intraoperative use with Apple Vision Pro and creating a new Class II device category for AR surgical software. On September 1, orthopedic surgeon Chad Mather III completed the inaugural authorized procedure at Duke Health, a hip arthroscopy for femoroacetabular impingement, using the headset to view arthroscopic video, CT imaging, and real-time surgical guidance within his field of view. The clearance opens a 510(k) predicate pathway for future competitors and marks the formal regulatory entry of spatial computing into the operating room.
The Clearance
Stryker submitted its De Novo request (DEN250040) for SportSuite Vision on September 2, 2025. The FDA issued its decision on July 17, 2026, 318 days later.
The authorization established a brand-new device classification: product code SIT under 21 CFR 888.1150, Class II, seated in the Office of Orthopedic Devices. The FDA defined the category as "augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery." That definition is broader than SportSuite Vision's own cleared indication, which is limited to femoroacetabular impingement and labral repair hip arthroscopy procedures.
The regulatory consequence matters. Because Stryker absorbed the De Novo burden, future AR surgical applications in this category can file a 510(k) demonstrating substantial equivalence rather than repeating a fresh De Novo. The agency also declined to grant Stryker a Predetermined Change Control Plan, which means any future software modifications to SportSuite Vision will require separate FDA review.
What the Device Does
SportSuite Vision runs on Apple Vision Pro and operates as a video see-through augmented reality display. The surgeon looks through the headset and sees the physical operating room, patient, and instruments in real time, while virtual panels overlay clinical data into the same field of view.
During a hip arthroscopy, the system surfaces four data streams: the live arthroscopic camera feed, output from Stryker's HipCheck software, HipMap FAI Analysis data, and CT imaging. HipMap builds a patient-specific 3D model of the hip for preoperative planning. HipCheck delivers real-time intraoperative feedback that guides cam lesion resection to a target alpha angle. Surgeons can arrange those virtual panels to fit their preferred workflow without moving their eyes to wall-mounted monitors across the room.
The FDA cleared the CT imaging display for informational reference only. Traditional monitors remain required as backup, and only the operating surgeon wears the headset. Other OR staff continue working from standard screens.
The First Case
Duke Health orthopedic surgeon Chad Mather III performed the first authorized procedure on September 1, 2026. Mather, who serves as a Stryker consultant, said the system let him "customize the placement of key clinical information to fit my workflow and access it within the sterile field."
Matt Moreau, Stryker's VP and GM of Sports Medicine, described the clearance as "a new chapter in digital surgery, giving surgeons a more intuitive and ergonomic way to access critical information when and where they need it."
Stryker has opened a waitlist for interested surgical teams. No pricing or broader rollout timeline has been disclosed.
The Context
Surgeons had been experimenting with Apple Vision Pro in operating rooms before this clearance, none of it formally authorized for surgical use. In April 2026, ScopeXR disclosed that its platform had supported hundreds of cataract surgeries since its first case in October 2025, with surgeons citing high-resolution imaging, improved ergonomics, and real-time remote collaboration. Those procedures relied on a different application and a different surgical workflow.
SportSuite Vision differs in that it's the first application to carry explicit FDA authorization for intraoperative use. The distinction separates clinical instrument from research tool.
Stryker's own Endoscopy and Sports Medicine division already sells HipCheck and HipMap as standalone software products. SportSuite Vision layers those existing tools into a spatial computing environment rather than replacing the underlying surgical logic.
The Market
The digital surgery market was valued at $1.48 billion in 2025, according to Research and Markets, and is projected to reach $5.36 billion by 2030, a compound annual growth rate of 28.3%. Extended reality applications in surgery are listed among the primary growth drivers.
The new SIT product code covers a wider class than hip arthroscopy alone: the FDA's classification language includes "arthroscopic or endoscopic video and medical imaging during orthopedic surgery." That scope gives any cleared competitor a broader foundation to build from than Stryker's own initial cleared indication.
Sources
- Stryker Introduces First-of-Its-Kind FDA-Authorized Surgical Application for Apple Vision Pro, Stryker Newsroom
- Stryker Introduces First-of-Its-Kind FDA-Authorized Surgical Application for Apple Vision Pro, PR Newswire
- Stryker's Vision Pro Surgery App Spent 318 Days at FDA and Came Back With a Device Class of Its Own, VR.org
- The Apple Vision Pro Was Used for a Successful Hip Surgery, Engadget
- FDA Authorizes Stryker SportSuite Vision, First Surgical Application for Apple Vision Pro, Syenza News
- SportSuite Vision Becomes the First FDA-Authorized OR App for Apple Vision Pro, Next in Surgery
- Stryker Launches FDA-Cleared Apple Vision Pro Surgical App, Yahoo Finance / Zacks
- FDA Authorizes First Surgical App for Apple Vision Pro, Spatial Insiders
- Apple Vision Pro Used for Hundreds of Cataract Surgeries in the Last Year, AppleInsider
- Dr. Eric Rosenberg Completes First Cataract Surgery Using Apple Vision Pro and ScopeXR, HIT Consultant
- SportSuite Vision Product Page, Stryker
Companies mentioned
Mainstay Digital · Spatial and 3D visualization for industrial companies