Cleared Traditional

Restoris Multi-Compartmental Knee System

K220930 · Mako Surgical Corp. · Orthopedic

Jun 2022

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K220930 is an FDA 510(k) clearance for the Restoris Multi-Compartmental Knee System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Mako Surgical Corp. (Weston, US). The FDA issued a Cleared decision on June 2, 2022, 63 days after receiving the submission on March 31, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K220930 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2022
Decision Date	June 02, 2022
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520