Cleared Traditional

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws

K182346 · Exactech, Inc. · Orthopedic

Nov 2018

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K182346 is an FDA 510(k) clearance for the TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws, 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 November 26, 2018, 90 days after receiving the submission on August 28, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K182346 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2018
Decision Date	November 26, 2018
Days to Decision	90 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