News and analysis on medical technology
FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

Stryker Says First Hip Surgery Done With De Novo-Authorized Apple Vision Pro App

SportSuite Vision, granted De Novo authorization on July 17, puts arthroscopic video, CT images and hip planning software into the surgeon's view through the headset; the first case was at Duke Health.

By News DeskSeptember 1, 20262 min read
A surgeon in scrubs wearing an Apple Vision Pro headset in an operating room, with floating panels of arthroscopic video and imaging.
A Stryker image of a surgeon wearing Apple Vision Pro with SportSuite Vision panels showing CT, arthroscopic video, HipCheck and HipMap views. Photo: Stryker · Company press image from Stryker's news release
FDA De Novonew device type · DEN250040FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • Stryker said on September 1, 2026 that a surgeon at Duke Health completed the first hip arthroscopy using its SportSuite Vision software on Apple Vision Pro.
  • The FDA granted the software De Novo request DEN250040 on July 17, 2026, creating a new device type for intraoperative augmented reality video see-through display systems in arthroscopic and orthopedic endoscopic surgery.
  • The indication covers display of arthroscopic video and imaging during femoroacetabular impingement and labral repair hip procedures, alongside traditional monitors for other operating room staff.

Stryker said on Tuesday that the first surgery using its SportSuite Vision software on Apple Vision Pro has been completed at Duke Health, about six weeks after the U.S. Food and Drug Administration granted the software De Novo authorization. The procedure was a hip arthroscopy, the company said in its announcement.

The FDA's De Novo database shows that the agency granted request DEN250040 for SportSuite Vision Software, submitted by Stryker Endoscopy of San Jose, Calif., on July 17, 2026, after receiving it on September 2, 2025. The decision created a new classification under regulation 888.1150: an arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system. De Novo is the FDA's route for new low-to-moderate-risk device types that have no predicate on the market. The record lists the request as a direct De Novo, reviewed by the FDA's orthopedic panel.

What the software shows

SportSuite Vision places arthroscopic video, CT imaging and the output of Stryker's HipCheck and HipMap software into a customizable spatial computing environment, so a surgeon can see that information alongside the physical operating room, according to Stryker. During arthroscopic procedures, surgeons often rely on several displays placed around the room, the company said, and the application is designed to reduce reliance on those monitors.

The authorized indication is narrow. Stryker's release states that the software is indicated for the intraoperative display of arthroscopic video and medical imaging during femoroacetabular impingement and labral repair hip arthroscopy procedures. Surgical tasks are performed through a video see-through augmented reality head-mounted display, and the virtual images are to be used by the surgeon together with traditional monitors used by other operating room staff, according to the labeling text in the release.

The FDA record indicates that the authorization did not include a predetermined change control plan, the mechanism that lets a manufacturer make certain pre-specified modifications without a new submission.

The first case

Chad Mather III, an orthopedic surgeon at Duke Health, performed the procedure. "Using spatial computing enabled me to customize the placement of key clinical information to fit my workflow and access it within the sterile field," he said in Stryker's announcement.

Matt Moreau, vice president and general manager of Stryker's sports medicine business, said the product brings "multiple streams of clinical information into a spatial computing environment." Stryker described SportSuite Vision as the first application authorized by the FDA for intraoperative use with Apple Vision Pro, a description repeated in MacTech's report on the announcement.

Stryker did not disclose pricing, how many hospitals will offer the application or when it will be broadly available.

Sources

  1. Stryker introduces first of its kind FDA-authorized surgical application for Apple Vision Pro with hip arthroscopy case at nationally recognized academic medical center, Stryker, September 1, 2026
  2. De Novo DEN250040: SportSuite Vision Software, U.S. Food and Drug Administration, July 17, 2026
  3. Stryker introduces an FDA-authorized surgical app for the Apple Vision Pro, MacTech, September 1, 2026