Cleared Traditional

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer

K183017 · Osteoremedies, LLC · Orthopedic

Jul 2019

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K183017 is an FDA 510(k) clearance for the Remedy Femoral Component 84mm, 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 July 25, 2019, 267 days after receiving the submission on October 31, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K183017 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2018
Decision Date	July 25, 2019
Days to Decision	267 days
Submission Type	Traditional
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