510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Depuy Ireland UC

Co. Cork Munster, IE

Depuy Ireland UC appears in FDA device records in Co. Cork Munster, IE. FDA records list 50 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
50
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 50 510(k) clearances for Depuy Ireland UC between 2018 and 2026. The busiest year on record is 2024, with 10. The most recent is 2026, with 5.

Clearances by year, as a table
510(k) clearance decisions for Depuy Ireland UC, by decision year
YearClearances
20181
20206
20217
20229
20239
202410
20253
20265
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWHSubstantially Equivalent
K260480VELYS™ Robotic-Assisted SolutionOLOSubstantially Equivalent
K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWLSubstantially Equivalent
K253624INHANCE™ Reverse Shoulder SystemPHXSubstantially Equivalent
K253551VELYS™ Hip NavigationQIHSubstantially Equivalent
K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsJWHSubstantially Equivalent
K251292RECLAIM Monobloc Revision Femoral StemLZOSubstantially Equivalent
K243977EMPHASYS Acetabular SystemLPHSubstantially Equivalent
K243248INHANCE INTACT™PKCSubstantially Equivalent
K242871ATTUNE™ Revision Hinge KneeKROSubstantially Equivalent
K242084EMPHASYS Acetabular Shell with RapiTite HALPHSubstantially Equivalent
K241000ATTUNE™ 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;JWHSubstantially Equivalent
K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP TechnologyMBHSubstantially Equivalent
K240211VELYS Robotic-Assisted SolutionOLOSubstantially Equivalent
K240639PINNACLETM Constrained Acetabular LinersKWZSubstantially Equivalent
K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemKROSubstantially Equivalent
K231522EMPHASYS™ Dual Mobility SystemLPHSubstantially Equivalent
K231873DePuy 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 ConditionalMEHSubstantially Equivalent
K231526CORAIL Cemented Femoral StemKWYSubstantially Equivalent
K233227VELYS™ Robotic-Assisted SolutionOLOSubstantially Equivalent
K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyMBHSubstantially Equivalent
K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidMBFSubstantially Equivalent
K233233EMPHASYS Femoral StemsLZOSubstantially Equivalent
K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemLPHSubstantially Equivalent
K231516INHANCE™ Shoulder System, Sterile Single Use InstrumentationMBFSubstantially Equivalent
K230295ATTUNE® Revision ConesMBHSubstantially Equivalent
K222296ARTICUL/EZE Ceramic HeadsLZOSubstantially Equivalent
K223211INHANCETM Shoulder System – Humeral Stems and StemlessPHXSubstantially Equivalent
K221462DePuy Reclaim Monobloc Revision Femoral StemLZOSubstantially Equivalent
K212746ATTUNE Revision ConesMBHSubstantially Equivalent
K221636EMPHASYS Acetabular SystemLPHSubstantially Equivalent
K221467INHANCETM Reverse Glenoid Peripheral PostsPHXSubstantially Equivalent
K220216C-Stem AMT LE ProsthesisJDISubstantially Equivalent
K212933INHANCETM Hybrid Anatomic Glenoid ImplantMBFSubstantially Equivalent
K212737INHANCE™ Reverse Shoulder SystemPHXSubstantially Equivalent
K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPMBHSubstantially Equivalent
K212710GLOBAL UNITE™ Platform Shoulder SystemPHXSubstantially Equivalent
K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertJWHSubstantially Equivalent
K211657EMPHASYS Femoral StemsLZOSubstantially Equivalent
K203694DELTA XTEND Reverse Shoulder SystemPHXSubstantially Equivalent
K210581Actis DuoFix Hip Prosthesis- CollarlessMEHSubstantially Equivalent
K203532BI-MENTUM™ ALTRX® Dual Mobility LinerLZOSubstantially Equivalent
K202769VELYS™ Robotic-Assisted SolutionOLOSubstantially Equivalent
K202248Attune Revision Sleeve LPS Femoral AdaptorsJWHSubstantially Equivalent
K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyMBHSubstantially Equivalent
K202098GLOBAL UNITE™ Platform Shoulder SystemPHXSubstantially Equivalent
K200854DePuy PINNACLE Dual Mobility LinerLPHSubstantially Equivalent
K193549SIGMA High Performance (HP) Partial Knee SystemHRYSubstantially Equivalent
K193057ATTUNE All-Polyethylene TibiaJWHSubstantially Equivalent
K170748GLOBAL UNITE Platform Shoulder SystemPHXSubstantially Equivalent

Registered establishments

FDA registered establishments for Depuy Ireland UC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30155162663015516266Depuy Ireland UCLoughbeg, Ringaskiddy, Co. Cork Munster Munster IE2026and 70 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0951-2023BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain