# K083644: Mako Surgical Tactile Guidance System-Hip

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jun 19, 2009 after 192 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K905070 (1991). 42 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 56 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.
- K010602: Vectorvision Hip, Brainlab AG (2001)
- K040368: Vectorvision Hip 3.0, Brainlab AG (2004) Summary page 1.
- K052213: Navigation SW Hip 3.1 on CI, Brainlab AG (2005) Summary page 1.
- K072716: Vector Vision Hip, Brainlab AG (2007) Summary page 1.
- K022364: Navitrack System Total Hip Replacement,Model 900.200, Orthosoft, Inc. (2003) Summary page 1.

## Most influential descendants
- K091998: Robotic Arm Interactive Orthopedic System-Hip (2009), 12 descendants of its own
- K093425: Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha (2010), 11 descendants of its own
- K121064: Makoplasty Total Hip Application, Rio Standard System (2012), 9 descendants of its own
- K141989: Makoplasty Total Hip Allpication, Rio Standard System (2014), 8 descendants of its own
- K170593: Mako Total Hip Application (2017), 7 descendants of its own

## Indications for use
The Tactile Guidance System - Hip 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 - Hip is indicated for use in surgical hip 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: Acetabular reaming during total hip arthoplasty (THA)

Source page: https://510kreport.com/device/K083644
Methodology: https://510kreport.com/methodology