# K170891: Mako Partial Knee Application

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: May 24, 2017 after 58 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). 41 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142530: Partial Knee Application (PKA), Mako Surgical Corporation (2015) Summary page 4.

## Most influential descendants
- K172301: Mako Partial Knee Application (2017), 1 descendant of its own
- K242373: Mako Shoulder Application (1.0) (2024), 0 descendants of its own

## Recalls of this device
- May 10, 2018 · Class II · Z-2794-2018: Out of tolerance.
- 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. The Implant systems with which the system is compatible: • Restoris Multicompartmental Knee System

Source page: https://510kreport.com/device/K170891
Methodology: https://510kreport.com/methodology