# K220930: Restoris Multi-Compartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical Corp.
- Decided: Jun 2, 2022 after 63 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- 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 K943462 (1994). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180612: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2018) Summary page 4.

## 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 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™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

Source page: https://510kreport.com/device/K220930
Methodology: https://510kreport.com/methodology