# K081867: Mako Surgical Tactile Guidance System Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Nov 25, 2008 after 147 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K905070 (1991). 37 ancestors in all.
76 later devices descend from it; 5 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072806: Mako Surgical Tactile Guidance System (TGS), Mako Surgical Corp. (2008) Summary page 1.
- K052851: Voyager Linux with Tactile Guidance System (TGS), Mako Surgical Corp. (2005) 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.

## Most influential descendants
- 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
- K182964: ROSA Knee System (2019), 29 descendants of its own

## Recalls of this device
- Sep 12, 2012 · Class II · Z-0385-2013: MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. 
- Jul 17, 2009 · Not classified · Z-0064-2010: Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Ass

## Indications for use
The Tactile Guidance System v2.0 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 v2.0 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 and/or patellofemoral knee replacement.

Source page: https://510kreport.com/device/K081867
Methodology: https://510kreport.com/methodology