Depuy Orthopaedics, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ATTUNE Revision Knee System510(k)Sep 4, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 4, 2026
DePuy ATTUNE Knee System510(k)May 22, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 22, 2026
CUPTIMIZE Advanced510(k)Aug 22, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 22, 2023
DePuy Corail AMT Hip Prosthesis510(k)Jan 6, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 6, 2022
DELTA XTEND Reverse Shoulder System510(k)Feb 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 19, 2021