# K093425: Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Feb 24, 2010 after 113 days
- Product code: OLO (Orthopedic 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: 10 generations back to K905070 (1991). 48 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091998: Robotic Arm Interactive Orthopedic System-Hip, Mako Surgical Corp. (2009) Summary page 1.
- K081867: Mako Surgical Tactile Guidance System Version 2.0, Mako Surgical Corp. (2008) Summary page 1.
- K010602: Vectorvision Hip, Brainlab AG (2001) Summary page 1.
- 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.
- K050615: Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000, Stryker Instruments (2005) Summary page 1.
- K022365: Stryker Navigation System - Hip Module, Stryker Instruments (2003) Summary page 1.

## Most influential descendants
- 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
- K191998: Mako Total Hip Application, Mako Total Knee Application (2019), 6 descendants of its own
- K193128: Mako Total Hip Application (2020), 3 descendants of its own

## Recalls of this device
- Aug 7, 2024 · Class II · Z-0044-2025: Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
- Jan 20, 2011 · Not classified · Z-0146-2012: MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reporte

## Indications for use
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and 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: o Unicondylar knee replacement and/or patellofemoral knee replacement o Total hip arthroplasty (THA)

Source page: https://510kreport.com/device/K093425
Methodology: https://510kreport.com/methodology