Cleared Traditional

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

K242377 · Osteoremedies, LLC · Orthopedic

Oct 2024

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K242377 is an FDA 510(k) clearance for the REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Osteoremedies, LLC (Germantown, US). The FDA issued a Cleared decision on October 2, 2024, 54 days after receiving the submission on August 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K242377 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2024
Decision Date	October 02, 2024
Days to Decision	54 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