Cleared Special

REMEDY Stemmed Knee Spacer

K223650 · Osteoremedies, LLC · Orthopedic

Jan 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K223650 is an FDA 510(k) clearance for the REMEDY Stemmed Knee Spacer, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on January 5, 2023, 30 days after receiving the submission on December 6, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K223650 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2022
Decision Date	January 05, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560