# K090763: Restoris Multicompartmental Knee (MCK) System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corporation
- Decided: Jun 17, 2009 after 86 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943462 (1994). 31 ancestors in all.
50 later devices descend from it; 4 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082172: Mako Modular Knee Compartmental Implant System, Mako Surgical Corporation (2008) Summary page 2.

## Most influential descendants
- K133039: Restoris Multicompartmental Knee System (2013), 26 descendants of its own
- K150307: RESTORIS Multicompartmental Knee System (2015), 25 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K133811: Restoris Porous Partial Knee System (2014), 19 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own

## Recalls of this device
- Mar 10, 2023 · Class II · Z-1386-2023: Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
- Mar 10, 2023 · Class II · Z-1385-2023: Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
- Jan 19, 2018 · Class II · Z-2051-2018: Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
- Jan 15, 2016 · Class II · Z-1031-2016: Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
- Jan 9, 2014 · Class II · Z-1132-2014: The product may be mislabeled and could result in the incorrect implant being used.

## Indications for use
RESTORIS MCK 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 post-traumatic 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 MCK is for single use only and is intended for implantation with bone cement.

Source page: https://510kreport.com/device/K090763
Methodology: https://510kreport.com/methodology