Medical Device Manufacturer · IE , Ringaskiddy

Depuy Ireland UC

47 submissions · 47 cleared · Since 2018
47
Total
47
Cleared
0
Denied

Depuy Ireland UC — FDA 510(k) Submissions

Depuy Ireland UC has submitted 47 FDA 510(k) premarket notifications since 2018, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Shoulder Prosthesis, Reverse Configuration, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer . Use the specialty filter in the sidebar to narrow results.

47 devices
1–25 of 47
INHANCE? Reverse Shoulder System
K253624 · PHX Shoulder Prosthesis,... · Orthopedic
Mar 2026 113d
VELYS? Hip Navigation
K253551 · LLZ System, Image Processing,... · Radiology
Mar 2026 112d
ATTUNE? Total Knee System; ATTUNE? Revision Sleeve LPS? Femoral Adaptors
K253197 · JWH Prosthesis, Knee,... · Orthopedic
Nov 2025 54d
RECLAIM Monobloc Revision Femoral Stem
K251292 · LZO Prosthesis, Hip,... · Orthopedic
May 2025 28d
EMPHASYS Acetabular System
K243977 · LPH Prosthesis, Hip,... · Orthopedic
Jan 2025 30d
INHANCE INTACT?
K243248 · PKC Prosthesis, Total... · Orthopedic
Dec 2024 73d
ATTUNE? Revision Hinge Knee
K242871 · KRO Prosthesis, Knee,... · Orthopedic
Nov 2024 59d
EMPHASYS Acetabular Shell with RapiTite HA
K242084 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2024 83d
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 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2024 90d
ATTUNE? Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
K240678 · MBH Prosthesis, Knee,... · Orthopedic
Jun 2024 99d
VELYS Robotic-Assisted Solution
K240211 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 132d
PINNACLETM Constrained Acetabular Liners
K240639 · KWZ Prosthesis, Hip,... · Orthopedic
Apr 2024 29d
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
K233980 · KRO Prosthesis, Knee,... · Orthopedic
Mar 2024 94d
EMPHASYS? Dual Mobility System
K231522 · LPH Prosthesis, Hip,... · Orthopedic
Feb 2024 265d
DePuy SUMMIT Porocoat Hip Prosthesis ? MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis ? MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis ? MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis ? MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis ? MR Conditional
K231873 · MEH Prosthesis, Hip,... · Orthopedic
Jan 2024 207d
CORAIL Cemented Femoral Stem
K231526 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Dec 2023 207d
VELYS? Robotic-Assisted Solution
K233227 · OLO Orthopedic Stereotaxic... · Orthopedic
Dec 2023 77d
ATTUNE? Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM? 3DP Technology
K232303 · MBH Prosthesis, Knee,... · Orthopedic
Dec 2023 132d
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
K230831 · MBF Prosthesis, Shoulder,... · Orthopedic
Nov 2023 231d
EMPHASYS Femoral Stems
K233233 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2023 13d
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
K232556 · LPH Prosthesis, Hip,... · Orthopedic
Sep 2023 28d
INHANCE? Shoulder System, Sterile Single Use Instrumentation
K231516 · MBF Prosthesis, Shoulder,... · Orthopedic
Jul 2023 57d
ATTUNE? Revision Cones
K230295 · MBH Prosthesis, Knee,... · Orthopedic
Mar 2023 36d
ARTICUL/EZE Ceramic Heads
K222296 · LZO Prosthesis, Hip,... · Orthopedic
Jan 2023 158d
INHANCETM Shoulder System ? Humeral Stems and Stemless
K223211 · PHX Shoulder Prosthesis,... · Orthopedic
Dec 2022 46d
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