# K150307: RESTORIS Multicompartmental Knee System

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corp.
- Decided: Mar 10, 2015 after 29 days
- Product code: NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943462 (1994). 33 ancestors in all.
25 later devices descend from it; 2 cite 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)
- K133039: Restoris Multicompartmental Knee System, Mako Surgical Corporation (2013) Summary page 5.

## Most influential descendants
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own
- K230952: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (2023), 4 descendants of its own
- K223528: Triathlon® Hinge Knee System (2023), 4 descendants of its own

## Indications for use
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: • Medial unicondylar • Lateral unicondylar • Patellofemoral • Medial bi-compartmental (medial unicondylar and patellofemoral) RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

Source page: https://510kreport.com/device/K150307
Methodology: https://510kreport.com/methodology