Cleared Traditional

ATTUNE? Total Knee System; ATTUNE? Revision Sleeve LPS? Femoral Adaptors

K253197 · Depuy Ireland UC · Orthopedic

Nov 2025

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K253197 is an FDA 510(k) clearance for the ATTUNE? Total Knee System; ATTUNE? Revision Sleeve LPS? Femoral Adaptors, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on November 19, 2025, 54 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K253197 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	November 19, 2025
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560