# K141989: Makoplasty Total Hip Allpication, Rio Standard System

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corporation
- Decided: Nov 13, 2014 after 114 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K905070 (1991). 50 ancestors in all.
8 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)
- K121064: Makoplasty Total Hip Application, Rio Standard System, Mako Surgical Corporation (2012) Summary page 4.

## Most influential descendants
- 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
- K193515: Mako Total Knee Application (2020), 1 descendant of its own

## Recalls of this device
- Jul 9, 2020 · Class II · Z-2745-2020: Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
- 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

## 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/K141989
Methodology: https://510kreport.com/methodology