K262251

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

510(k) number
K262251
Device name
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
Applicant
Globus Medical, Inc. PA · US
Product code
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
Decision date
2026-07-31
Date received
2026-07-01
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K262251.pdf

Official FDA record: K262251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.