Overview
The MAKO SmartRobotics™ system is Stryker's flagship robotic arm platform for joint replacement surgery. First introduced in 2006 for partial knee procedures and expanded to total knee and total hip arthroplasty, MAKO has become the gold standard for precision orthopedic robotics globally.
The system combines pre-operative CT-based 3D planning with intraoperative haptic guidance, creating a virtual boundary that the surgeon's robotic arm cannot exceed. This "AccuStop™" technology enables accurate implant positioning even as soft tissue moves during surgery.
As of 2025, over 1.5 million procedures have been performed on more than 1,200 installed systems worldwide, making MAKO the most widely deployed surgical robot in orthopedics.
Key Technology
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CT-Based 3D Planning
Pre-operative CT scan generates a patient-specific 3D bone model. Surgeon plans implant size, position, and alignment virtually before the first incision.
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AccuStop™ Haptic Guidance
Robotic arm provides physical resistance when approaching boundaries, preventing over-resection and keeping bone removal precisely within the planned zone.
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Real-Time Intraoperative Tracking
Optical tracking array registers patient anatomy intraoperatively, compensating for soft tissue shifts and leg repositioning throughout the case.
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Soft Tissue Balancing
Dynamic ligament balancing data guides gap analysis in real-time, helping surgeons achieve optimal flexion-extension gaps for TKA cases.
Indications & Applications
Total Knee Arthroplasty (TKA)
Partial Knee Arthroplasty (PKA)
Total Hip Arthroplasty (THA)
Total Shoulder Arthroplasty (TSA)
Revision TKA
MAKO is indicated for patients with osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis requiring joint replacement. Clinical studies show MAKO-assisted TKA achieves superior component alignment vs. manual technique, with reduced outlier rates in coronal alignment and tibial slope.
Clinical Evidence
RCT
MAKO TKA vs Manual TKA (Bhimani et al., 2022)
Randomized controlled trial showing robotic TKA achieved statistically significant improvements in coronal alignment accuracy (96% vs 84% within 3° of target) and reduced revision rates at 2-year follow-up.
Registry
Australian Orthopaedic Association Registry (AOANJRR)
Large registry data showing robotic-assisted TKA with cementless fixation demonstrates lower revision rates compared to conventional cemented techniques at 5-year follow-up.
Meta-Analysis
MAKO THA Outcomes (Kayani et al., 2020)
Systematic review of 1,200+ robotic THA cases demonstrating superior acetabular component positioning, reduced dislocation risk, and faster functional recovery vs. conventional technique.
Regulatory History
2006
Initial 510(k) clearance for partial knee arthroplasty
2015
Stryker acquires Mako Surgical Corp; integration into joint replacement portfolio
2017
510(k) clearance expanded to Total Hip Arthroplasty
2019
Total Knee Arthroplasty clearance; becomes full lower extremity platform
2022
Total Shoulder Arthroplasty clearance added
2025
1.5M+ cumulative procedures milestone; active expansion in Asia-Pacific