# K170584: Mako Partial 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: 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.
2 later devices descend from it; 1 cites it directly.
0 of 42 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
- K210121: ROSA Partial Knee System (2021), 1 descendant of its own
- K232533: ROSA Partial Knee System (2023), 0 descendants of its own

## Recalls of this device
- Dec 27, 2017 · Class II · Z-3182-2018: Communication-connection error.
- Dec 1, 2017 · Class II · Z-1644-2018: Incorrect product and/or label. Sizing is labeled incorrectly.

## Indications for use
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.

Source page: https://510kreport.com/device/K170584
Methodology: https://510kreport.com/methodology