Cleared Traditional

Exactech? TRULIANT? Knee System

K240393 · Exactech, Inc. · Orthopedic

Oct 2024

Decision

238d

Days

Class 2

Risk

About This 510(k) Submission

K240393 is an FDA 510(k) clearance for the Exactech? TRULIANT? Knee System, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 3, 2024, 238 days after receiving the submission on February 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K240393 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2024
Decision Date	October 03, 2024
Days to Decision	238 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565