3,000 Systems. 50% of Global Knee Procedures. Robotic Surgery Is No Longer Optional.
The single most structurally significant statistic in the orthopedic devices market in 2026 is one that took a decade of commercial development to reach: more than 50% of global knee implant procedures and over 20% of global hip implant procedures were performed using Stryker’s MAKO robotic systems at year-end 2025, according to Gabelli’s April 2026 Orthopedics Market analysis — an industry research publication from the investment firm. Stryker has 3,000 MAKO systems installed worldwide at year-end 2025, up from more than 2,000 at year-end 2024. For Stryker specifically, the Gabelli analysis confirmed that MAKO robotic surgery is becoming the standard of care in the U.S., with over two-thirds of U.S. knee surgeries performed with MAKO. The competitive consequence is direct: robotic surgery is no longer a premium differentiator that some orthopedic practices offer and others do not. It is the standard against which practice quality is increasingly being measured by patients, referring physicians, and health system procurement teams. Zimmer Biomet’s ROSA knee system and Smith & Nephew’s Navio platform are competitive alternatives, but Stryker’s first-mover advantage — dating from its 2013 acquisition of MAKO Surgical — has produced an installed base and procedural volume lead that its competitors are working to overcome.
MAKO RPS: Robotics Entering the Ambulatory Surgery Centre
The most strategically consequential product launch anticipated in mid-2026 is not another high-complexity hospital system. It is Stryker’s MAKO RPS — a handheld robotic version of the MAKO system specifically engineered for ambulatory surgery centre settings. The significance of this is about market structure, not just product specification. Ambulatory surgery centres perform an increasing share of the United States’ elective orthopedic procedure volume, driven by cost structure, patient preference for same-day discharge, and the expansion of the ASC-covered procedures list by the Centers for Medicare & Medicaid Services. Until MAKO RPS, the MAKO platform required a dedicated suite and a capital footprint that most ASCs could not accommodate. A handheld system designed specifically for ASC workflows changes that equation, potentially extending robotic-assisted orthopedic surgery’s addressable market to the thousands of U.S. ASCs that currently perform knee and hip replacement procedures without robotic assistance. Gabelli’s analysis forecast that both the knee and hip markets would perform well in 2026 due to healthy patient volumes, growing ASC capacity, and hospitals managing capacity well.
Shoulder Robotics: The Newest Frontier Getting Its Commercial Debut
The orthopedic robotics story in 2026 is not only about the established knee and hip applications. Orthopedics Market Update documented that in late 2024, both Stryker and Zimmer Biomet received FDA approval for shoulder applications on their respective robotic systems — the first time shoulder reconstructive surgery has been addressable through robotic assistance at these companies. Both are planning limited launches with careful training protocols before broader market commercialisation in 2026. The shoulder application is particularly technically demanding: the anatomical complexity of the shoulder joint, the diversity of shoulder pathology requiring reconstruction, and the proximity of critical neurovascular structures make robotic guidance valuable but require a higher degree of surgeon training and system refinement than knee procedures. The limited launch approach reflects an appropriate clinical caution rather than any doubt about the technology’s eventual commercial trajectory.
The Market Share Map: Zimmer Biomet Leads Knees, Stryker Leads Hips
The competitive structure of the global knee and hip implant market is defined by four companies holding approximately 80% or more of combined market share. In the knee market: Zimmer Biomet at 33%, Stryker at 30%, J&J DePuy at 16%, and Smith & Nephew at 11%. In the hip market: Stryker at 26%, Zimmer Biomet at 25%, J&J DePuy at 20%, and Smith & Nephew at 8%. Price declined by approximately 1% within historical levels in 2025 — a continuation of the modest, consistent pricing pressure that characterises mature implant markets. The most consequential recent strategic decision in the competitive landscape was Stryker’s sale of its spinal implant business segment to Viscogliosi Brothers in January 2025, creating VB Spine LLC — a move that concentrated Stryker’s focus on its strongest positions in knees, hips, and robotic-assisted surgery while allowing a dedicated spine specialist to take ownership of the divested portfolio.
Tariffs and Supply Chain: An Industry Built in America, Navigating a Complex Environment
The orthopedic device industry’s domestic manufacturing base provides meaningful insulation from the tariff environment reshaping other medtech categories in 2026. Most orthopedic companies manufacture their implants in the U.S. and that Mexico and Canada facilities’ products are largely exempt from tariffs under the USMCA trade agreement. Larger orthopedic manufacturers, with greater supply chain diversification and the ability to qualify multiple suppliers, are better positioned than smaller operators to absorb any residual cost impacts. This domestic manufacturing profile is not accidental: orthopedic implant manufacturing requires precision machining, stringent biocompatibility validation, and close proximity to the clinical teams providing feedback on implant design — characteristics that have historically favoured domestic production even before the current reshoring policy environment made that preference explicit.
What the Orthopedic Devices Market Looks Like as Robotics Becomes Universal
Constancy Researchers’ assessment: the orthopedic devices market in 2026 is navigating the transition from a market in which robotic surgery is a differentiating premium to a market in which it is the standard of care expectation, and the companies best positioned are those that reached meaningful installed-base scale before that transition completed. Stryker’s 3,000 MAKO installations and 50%+ global knee procedure robotics penetration represent a moat of clinical familiarity, training infrastructure, and implant ecosystem integration that competitors are structurally challenged to close quickly. The MAKO RPS launch for ASCs represents the next wave of that moat’s extension — taking the robotics advantage into the care setting that is growing fastest in the U.S. orthopedic procedure volume mix. Zimmer Biomet’s ROSA platform and Smith & Nephew’s Navio system provide genuine competitive alternatives, and both companies’ limited shoulder application launches reflect the category’s continued geographic and procedural expansion. But the fundamental competitive dynamic has been set: the company that built the largest robotic installed base earliest will benefit from that decision for the next decade of the market’s development.
Looking to navigate geopolitical risks and identify new industry opportunities?
Connect with Constancy Researchers for data-driven insights, geopolitical intelligence, and strategic consulting tailored to your business needs.
