Versius vs Stryker Mako SmartRobotics in 2026

Versius

CMR Surgical's Versius (and Versius Plus) is a modular, multi-arm, soft-tissue minimal-access surgical robot from UK-based CMR Surgical, and the international-soft-tissue archetype of DEPLOY's surgical cluster. Its modular multi-arm architecture is a deliberate contrast to the monolithic design of Intuitive's da Vinci: it is teleoperated and software-driven, capturing telematic, video, and outcome data.

On regulatory status (a correction worth recording): Versius is US-FDA-cleared for cholecystectomy via a De Novo authorization in October 2024, with Versius Plus cleared via 510(k) on December 18, 2025 (also cholecystectomy) and a gynecology 510(k) submitted April 29, 2026 (pending); it is not broadly 'US-pending', only the gynecology indication is. It is CE-marked and commercial across Europe, Latin America, AMEA, and Australia. As enterprise B2B surgical equipment sold to hospitals, there is no consumer price.

Stryker Mako SmartRobotics

Stryker's Mako (Mako SmartRobotics) is a surgeon-guided robotic arm for orthopedic joint replacement and the large-footprint, CT-based, multi-procedure archetype of DEPLOY's orthopedic surgical sub-cohort. It pairs CT-based 3D pre-operative planning with intra-operative haptic boundary control (AccuStop physically constrains the saw or burr to the planned resection zone) and real-time optical bone tracking.

Critically, it is AI-augmented but surgeon-controlled, not autonomous: the surgeon holds and guides the arm and makes every cut; the robot does not move or cut on its own, the same assistive class as Intuitive's da Vinci. Cleared procedures span partial and total knee (total knee August 2015), cementless total knee, total hip and a hip-revision feature, Mako Spine (510(k) K241517, May 2024, pedicle-screw placement) and Mako Shoulder 1.0 (510(k) K242373, November 2024, reverse shoulder arthroplasty).

Sold in 45-plus countries by Stryker (NYSE: SYK). Cap-flag: Stryker frames itself in SEC filings as one of four leading global competitors, not a specific market-share percentage; aggregator share figures are not verified. As enterprise B2B surgical equipment, there is no consumer price.