Cleared Traditional

ATTUNE? Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM? NOILES? Rotating Hinge Knee System; DePuy P.F.C. ? SIGMA? Total Knee System; DePuy SIGMA? Total Knee System;

K241000 · Depuy Ireland UC · Orthopedic

Jul 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K241000 is an FDA 510(k) clearance for the ATTUNE? Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM? NOILES? Rotating Hinge Knee System; DePuy P.F.C. ? SIGMA? Total Knee System; DePuy SIGMA? Total Knee System;, 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 July 11, 2024, 90 days after receiving the submission on April 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K241000 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2024
Decision Date	July 11, 2024
Days to Decision	90 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