Cleared Traditional

TRULIANT? E-PX Tibial Inserts; TRULIANT? E-PX Patellas

K223252 · Exactech, Inc. · Orthopedic

Jul 2023

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K223252 is an FDA 510(k) clearance for the TRULIANT? E-PX Tibial Inserts; TRULIANT? E-PX Patellas, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on July 17, 2023, 269 days after receiving the submission on October 21, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K223252 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2022
Decision Date	July 17, 2023
Days to Decision	269 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