K241000

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;

510(k) number: K241000
Device name: 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;
Applicant: Depuy Ireland UC IE
Product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
Decision date: 2024-07-11
Date received: 2024-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

PDFDownload 510(k) SummaryArchived here · 4.2 MB · U.S. public domain

Also available from FDA: K241000.pdf

Official FDA record: K241000

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.