# K143752: Total Knee Application (TKA)

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Aug 6, 2015 after 218 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). 39 ancestors in all.
44 later devices descend from it; 3 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System, Mako Surgical Corporation (2012) Summary page 4.

## Most influential descendants
- 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
- K230202: TMINI™ Miniature Robotic System (2023), 10 descendants of its own
- K232802: TMINI™ Miniature Robotic System (2023), 9 descendants of its own

## Recalls of this device
- Apr 25, 2019 · Class II · Z-1823-2019: The bearings of the saw attachments were ungreased.
- Apr 25, 2019 · Class II · Z-1824-2019: The bearings of the saw attachments were ungreased.

## 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 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: » Total Knee Arthroplasty (TKA) The Implants systems with which the system is compatible: » Kinetis Total Knee System { CR/UC) Triathlon Total Knee System ( CR/CS/PS cemented Primary)

Source page: https://510kreport.com/device/K143752
Methodology: https://510kreport.com/methodology