DePuy Orthopaedics, Inc. is one of 16067 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
DePuy Orthopaedics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ATTUNE Revision Knee System, DePuy ATTUNE™ Knee System, CUPTIMIZE™ Advanced
208
Total
206
Cleared
0
Denied
DePuy Orthopaedics, Inc. has 206 FDA 510(k) cleared orthopedic devices. Based in Warsaw, US.
Latest FDA clearance: Sep 2026. Active since 1998.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Depuy(Ireland), DePuy Synthes and Depuy Ireland UC.
FDA 510(k) Regulatory Record - DePuy Orthopaedics, Inc.
208 devices
Cleared
Sep 04, 2026
ATTUNE Revision Knee System
Orthopedic
72d
Cleared
May 22, 2026
DePuy ATTUNE™ Knee System
Orthopedic
254d
Cleared
Aug 22, 2023
CUPTIMIZE™ Advanced
Radiology
90d
Cleared
Jan 06, 2022
DePuy Corail AMT Hip Prosthesis
Orthopedic
28d
Cleared
Feb 19, 2021
DELTA XTEND Reverse Shoulder System
Orthopedic
29d
Cleared
Nov 19, 2020
DePuy Corail AMT Hip Prosthesis
Orthopedic
27d
Cleared
Oct 21, 2020
ACTIS Duofix Hip Prosthesis
Orthopedic
54d
Cleared
Jun 18, 2020
DePuy ATTUNE™ Total Knee System
Orthopedic
28d
Cleared
Jun 16, 2020
TRUMATCH Personalized Solutions
Orthopedic
179d
Cleared
Feb 04, 2020
Summit DuoFix HA Coating
Orthopedic
60d
Cleared
Nov 26, 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
Orthopedic
42d
Cleared
Nov 26, 2019
DePuy Corail AMT Hip Prosthesis
Orthopedic
39d
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