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The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Tactile Guidance System is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:

Unicondylar knee replacement .

The TGS is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS robotic arm. TGS uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS robotic arm, which is an add-on to the Navigation Module, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS robotic arm, an electromechanical arm, is passively constrained by softwaredefined spatial boundaries implemented through the use of the TGS robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 3rd party drill systems.

This document, K072806, describes the MAKO Surgical Corp.'s Tactile Guidance System (TGS). It details the device, its intended use, and claims substantial equivalence to several predicate devices. However, this submission does not contain acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the provided text as it is not present.

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