Cleared Traditional

K190633 - NanoOrtho NanoKnee? System
(FDA 510(k) Clearance)

K190633 · Nanoortho, LLC · Orthopedic

Dec 2019

Decision

283d

Days

Class 2

Risk

K190633 is an FDA 510(k) clearance for the NanoOrtho NanoKnee? System, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Nanoortho, LLC (Arroyo Grande, US). The FDA issued a Cleared decision on December 20, 2019, 283 days after receiving the submission on March 12, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number	K190633 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2019
Decision Date	December 20, 2019
Days to Decision	283 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3530