Cleared Traditional

ATTUNE? Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

K240678 · Depuy Ireland UC · Orthopedic

Jun 2024

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K240678 is an FDA 510(k) clearance for the ATTUNE? Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on June 18, 2024, 99 days after receiving the submission on March 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K240678 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2024
Decision Date	June 18, 2024
Days to Decision	99 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