# K142530: Partial Knee Application (PKA)

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corporation
- Decided: Sep 16, 2015 after 372 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- 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.
3 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)
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System, Mako Surgical Corporation (2012) Summary page 4.
- K143752: Total Knee Application (TKA), Mako Surgical Corp. (2015). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K170891: Mako Partial Knee Application (2017), 2 descendants of its own
- K172301: Mako Partial Knee Application (2017), 1 descendant of its own
- K242373: Mako Shoulder Application (1.0) (2024), 0 descendants of its own

## Indications for use
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (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 unicondylar knee replacement and/or patellofemoral knee replacement. The Implant systems with which the system is compatible: Restoris Multicompartmental Knee System Restoris Porous Partial Knee System

Source page: https://510kreport.com/device/K142530
Methodology: https://510kreport.com/methodology