# K121064: Makoplasty Total Hip Application, Rio Standard System

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corporation
- Decided: Jun 6, 2012 after 61 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K905070 (1991). 49 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093425: Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha, Mako Surgical Corp. (2010) Summary page 1.

## Most influential descendants
- 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
- K243751: Mako Total Hip Application 5.0 (2025), 1 descendant of its own

## Recalls of this device
- Aug 8, 2022 · Class II · Z-1735-2022: Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
- Jul 24, 2018 · Class II · Z-2925-2018: Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detect
- Aug 7, 2017 · Class II · Z-3131-2017: Software discrepancy of not showing all the EE constants, when the screen is filled.
- Dec 22, 2016 · Class II · Z-1411-2017: Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
- Sep 29, 2016 · Class II · Z-1193-2017: Failure of the Offset Cup Reamer Handle not engaging its mating components.
- Feb 23, 2016 · Class II · Z-1583-2016: Potential disassociation of the orientation pin.
- Nov 25, 2015 · Class II · Z-1588-2016: Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product ta
- Jul 16, 2015 · Class II · Z-0224-2016: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
- Oct 7, 2014 · Class II · Z-0830-2015: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
- Oct 7, 2014 · Class II · Z-0828-2015: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
- Oct 7, 2014 · Class II · Z-0829-2015: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
- Apr 30, 2014 · Class II · Z-1508-2016: Revision of the field manual

## 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 istructures 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 Unicondyhar knee replacement and/or patellofemoral knee replacement o, Total hip arthroplasty (TEA)

Source page: https://510kreport.com/device/K121064
Methodology: https://510kreport.com/methodology