# K193515: Mako Total Knee Application

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jul 14, 2020 after 208 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K905070 (1991). 57 ancestors in all.
1 later device descends 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)
- K191998: Mako Total Hip Application, Mako Total Knee Application, Mako Surgical Corp. (2019) Summary page 4.

## Most influential descendants
- K240721: ExcelsiusFlex™ (2024), 0 descendants of its own

## Recalls of this device
- Apr 15, 2024 · Class II · Z-1912-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1910-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1911-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1914-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1913-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo
- Apr 15, 2024 · Class II · Z-1915-2024: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdo

## 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 implant systems compatible with the system: * Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary) * Triathlon Total Knee System (TS inserts cemented primary) * Kinetis Total Knee System (CR/UC)

Source page: https://510kreport.com/device/K193515
Methodology: https://510kreport.com/methodology