# K072806: Mako Surgical Tactile Guidance System (TGS)

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jan 24, 2008 after 115 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K905070 (1991). 36 ancestors in all.
78 later devices descend from it; 2 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052851: Voyager Linux with Tactile Guidance System (TGS), Mako Surgical Corp. (2005) Summary page 1.
- K062146: Uni Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.
- K031454: Acumen Surgical Navigation System, Biomet, Inc. (2004) Summary page 1.
- K031337: Acumen Surgical Navigation System, Biomet, Inc. (2003) Summary page 1.
- K041899: Vectorvision Uni-Knee, Brainlab AG (2004) Summary page 1.
- K071714: Navitrack System - OS Unicondylar Knee Universal, Model#  Pro-06003, Orthosoft, Inc. (2007) Summary page 1.

## Most influential descendants
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), 76 descendants of its own
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System (2012), 46 descendants of its own
- K143752: Total Knee Application (TKA) (2015), 44 descendants of its own
- K170581: Mako Total Knee Application (2017), 38 descendants of its own
- K172219: Mako Total Knee Application (2017), 37 descendants of its own

## Recalls of this device
- May 2, 2008 · Not classified · Z-0915-2009: The product in its current state may fail during use, which would cause the instrument to be in-accurate.

## Indications for use
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

Source page: https://510kreport.com/device/K072806
Methodology: https://510kreport.com/methodology