Cleared Traditional

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

K232303 · Depuy Ireland UC · Orthopedic

Dec 2023

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K232303 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 (Ringaskiddy, IE). The FDA issued a Cleared decision on December 11, 2023, 132 days after receiving the submission on August 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K232303 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2023
Decision Date	December 11, 2023
Days to Decision	132 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