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The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.

The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.

The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications:

• Enovis™ EMPOWR Knee System®
• Ortho Development® BKS® and BKS TriMax® Knee System
• Total Joint Orthopedics Klassic® Knee System
• United® U2™ Knee Total Knee System
• Medacta® GMK® Sphere / SpheriKA Knee Systems
• Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
• b-ONE MOBIO® Total Knee System
• Maxx Orthopedics Freedom® Total & Titan Knee
• LINK® LinkSymphoKnee System

The TMINI® Miniature Robotic System (AIM 3.0) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation with the TCM web based plan review, approval and download component, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. This submission introduces modifications to the method of generation, verification and validation of new implant modules for use with the TMINI Miniature Robotic System.

The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.

The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.

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