# K170581: Mako Total Knee Application

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corp.
- Decided: May 11, 2017 after 72 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (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). 40 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143752: Total Knee Application (TKA), Mako Surgical Corp. (2015) Summary page 4.

## Most influential descendants
- 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
- K241031: TMINI Miniature Robotic System (TMINI 1.1) (2024), 8 descendants of its own

## Recalls of this device
- Dec 27, 2017 · Class II · Z-3182-2018: Communication-connection error.

## Indications for use
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System 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 compatible with this system: • Triathlon Total Knee System (CR/CS/PS cemented Primary) • Kinetis Total Knee System (CR/UC)

Source page: https://510kreport.com/device/K170581
Methodology: https://510kreport.com/methodology