Cleared Traditional

Unity Knee PS-C Tibial Insert

K240875 · Corin U.S.A. Limited · Orthopedic

Jun 2024

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K240875 is an FDA 510(k) clearance for the Unity Knee PS-C Tibial Insert, 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 June 26, 2024, 89 days after receiving the submission on March 29, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K240875 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2024
Decision Date	June 26, 2024
Days to Decision	89 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