Cleared Special

Truliant Porous Femoral Components

K181794 · Exactech, Inc. · Orthopedic

Sep 2018

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K181794 is an FDA 510(k) clearance for the Truliant Porous Femoral Components, 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 September 28, 2018, 85 days after receiving the submission on July 5, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K181794 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2018
Decision Date	September 28, 2018
Days to Decision	85 days
Submission Type	Special
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