Cleared Traditional

ATTUNE? Revision Cones

K230295 · Depuy Ireland UC · Orthopedic

Mar 2023

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K230295 is an FDA 510(k) clearance for the ATTUNE? Revision Cones, 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 March 10, 2023, 36 days after receiving the submission on February 2, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K230295 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2023
Decision Date	March 10, 2023
Days to Decision	36 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