# K112507: Restoris Partial Knee Application (Pka), Rio Standard System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corporation
- Decided: Mar 1, 2012 after 184 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: 9 generations back to K905070 (1991). 38 ancestors in all.
46 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081867: Mako Surgical Tactile Guidance System Version 2.0, Mako Surgical Corp. (2008) Summary page 1.

## Most influential descendants
- K143752: Total Knee Application (TKA) (2015), 44 descendants of its own
- K170581: Mako Total Knee Application (2017), 38 descendants of its own
- 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

## Recalls of this device
- Jul 24, 2018 · Class II · Z-2924-2018: Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detect
- Aug 7, 2017 · Class II · Z-3130-2017: Software discrepancy of not showing all the EE constants, when the screen is filled.
- Jun 7, 2017 · Class II · Z-2741-2017: An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
- Jul 16, 2015 · Class II · Z-0224-2016: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
- Jan 22, 2015 · Class II · Z-1128-2015: When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be ac
- Apr 30, 2014 · Class II · Z-1508-2016: Revision of the field manual

## Indications for use
The Restoris 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 Restoris 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.

Source page: https://510kreport.com/device/K112507
Methodology: https://510kreport.com/methodology