Chrysalis Intelligence · Sponsors · Depuy Ireland UC

Depuy Ireland UC

Ringaskiddy, IE · 49 510(k) clearances · 1 recalls

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Total clearances
49
2020-01-30 → 2026-06-25
Last 12 months
6
Product codes
16
Most recent
2026-06-25
Name variants in FDA filings: Depuy Ireland UC / DePuy Ireland UC
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 7 2026-03-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II Orthopedic 6 2026-06-25
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class II Orthopedic 6 2025-05-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II Orthopedic 6 2025-01-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class II Orthopedic 6 2024-06-18
OLO Orthopedic Stereotaxic Instrument Class II Neurology 4 2026-06-25
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class II Orthopedic 3 2023-11-13
KRO — — — 2 2024-11-21
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class II Orthopedic 2 2024-01-19
KWL — — — 1 2026-05-15
QIH Automated Radiological Image Processing Software Class II Radiology 1 2026-03-06
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II Orthopedic 1 2024-12-23
KWZ — — — 1 2024-04-04
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class II Orthopedic 1 2023-12-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class II Orthopedic 1 2022-07-22
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class II Orthopedic 1 2020-04-16
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2022-12-19
DateSeverityStatusRecall # ProductCodeReason
2022-12-19 Class II Ongoing Z-0951-2023 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 1… — All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended …
Filings

All 510(k) clearances (49)

Date K-number Device Code Class Specialty
2026-06-25 K261458 ATTUNE Total Knee System; ATTUNE Cementless Knee System JWH Class II Orthopedic
2026-06-25 K260480 VELYS™ Robotic-Assisted Solution OLO Class II Neurology
2026-05-15 K260536 Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement KWL — —
2026-03-11 K253624 INHANCE™ Reverse Shoulder System PHX Class II Orthopedic
2026-03-06 K253551 VELYS™ Hip Navigation QIH Class II Radiology
2025-11-19 K253197 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors JWH Class II Orthopedic
2025-05-23 K251292 RECLAIM Monobloc Revision Femoral Stem LZO Class II Orthopedic
2025-01-22 K243977 EMPHASYS Acetabular System LPH Class II Orthopedic
2024-12-23 K243248 INHANCE INTACT™ PKC Class II Orthopedic
2024-11-21 K242871 ATTUNE™ Revision Hinge Knee KRO — —
2024-10-07 K242084 EMPHASYS Acetabular Shell with RapiTite HA LPH Class II Orthopedic
2024-07-11 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; JWH Class II Orthopedic
2024-06-18 K240678 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology MBH Class II Orthopedic
2024-06-05 K240211 VELYS Robotic-Assisted Solution OLO Class II Neurology
2024-04-04 K240639 PINNACLETM Constrained Acetabular Liners KWZ — —
2024-03-21 K233980 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System KRO — —
2024-02-15 K231522 EMPHASYS™ Dual Mobility System LPH Class II Orthopedic
2024-01-19 K231873 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 MEH Class II Orthopedic
2023-12-19 K231526 CORAIL Cemented Femoral Stem KWY Class II Orthopedic
2023-12-14 K233227 VELYS™ Robotic-Assisted Solution OLO Class II Neurology
2023-12-11 K232303 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology MBH Class II Orthopedic
2023-11-13 K230831 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid MBF Class II Orthopedic
2023-10-11 K233233 EMPHASYS Femoral Stems LZO Class II Orthopedic
2023-09-20 K232556 DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System LPH Class II Orthopedic
2023-07-21 K231516 INHANCE™ Shoulder System, Sterile Single Use Instrumentation MBF Class II Orthopedic
2023-03-10 K230295 ATTUNE® Revision Cones MBH Class II Orthopedic
2023-01-06 K222296 ARTICUL/EZE Ceramic Heads LZO Class II Orthopedic
2022-12-02 K223211 INHANCETM Shoulder System – Humeral Stems and Stemless PHX Class II Orthopedic
2022-10-21 K221462 DePuy Reclaim Monobloc Revision Femoral Stem LZO Class II Orthopedic
2022-10-17 K212746 ATTUNE Revision Cones MBH Class II Orthopedic
2022-09-06 K221636 EMPHASYS Acetabular System LPH Class II Orthopedic
2022-08-31 K221467 INHANCETM Reverse Glenoid Peripheral Posts PHX Class II Orthopedic
2022-07-22 K220216 C-Stem AMT LE Prosthesis JDI Class II Orthopedic
2022-06-08 K212933 INHANCETM Hybrid Anatomic Glenoid Implant MBF Class II Orthopedic
2022-04-21 K212737 INHANCE™ Reverse Shoulder System PHX Class II Orthopedic
2022-01-18 K213781 ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP MBH Class II Orthopedic
2021-09-15 K212710 GLOBAL UNITE™ Platform Shoulder System PHX Class II Orthopedic
2021-08-25 K211609 ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert JWH Class II Orthopedic
2021-08-05 K211657 EMPHASYS Femoral Stems LZO Class II Orthopedic
2021-07-22 K203694 DELTA XTEND Reverse Shoulder System PHX Class II Orthopedic
2021-05-20 K210581 Actis DuoFix Hip Prosthesis- Collarless MEH Class II Orthopedic
2021-04-28 K203532 BI-MENTUM™ ALTRX® Dual Mobility Liner LZO Class II Orthopedic
2021-01-14 K202769 VELYS™ Robotic-Assisted Solution OLO Class II Neurology
2020-12-28 K202248 Attune Revision Sleeve LPS Femoral Adaptors JWH Class II Orthopedic
2020-11-25 K202194 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology MBH Class II Orthopedic
2020-11-25 K202098 GLOBAL UNITE™ Platform Shoulder System PHX Class II Orthopedic
2020-09-11 K200854 DePuy PINNACLE Dual Mobility Liner LPH Class II Orthopedic
2020-04-16 K193549 SIGMA High Performance (HP) Partial Knee System HRY Class II Orthopedic
2020-01-30 K193057 ATTUNE All-Polyethylene Tibia JWH Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence