Cleared Traditional

Unity Total Knee System

K241570 · Corin U.S.A. Limited · Orthopedic

Sep 2024

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K241570 is an FDA 510(k) clearance for the Unity Total Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on September 23, 2024, 115 days after receiving the submission on May 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K241570 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2024
Decision Date	September 23, 2024
Days to Decision	115 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