Data / Medical devices / Ireland / Depuy Ireland UC
Depuy Ireland UC: FDA-registered device maker in Co. Cork Munster, Ireland, 86 510(k) clearances and 2 PMA approvals
Depuy Ireland UC is registered with the FDA (registration 3015516266) in Co. Cork Munster, Ireland. It lists 80 device types. The FDA files 86 510(k) clearances and 2 PMA approvals under its listings, the newest dated September 4, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015516266
- Address
- Loughbeg, Ringaskiddy, Co. Cork Munster, Ireland, Munster
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 1977
- Registered through
- 2027
- Brand names listed
- ACCESSORY, ARICULATED TENSION DEVICE SYNTHES TEN, ATTUNE All Polyethylene Tibia, ATTUNE Medial Stabilized Fixed Bearing (MS FB) Inserts, ATTUNE Medial Stabilized Fixed Bearing Insert, ATTUNE Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP Technology, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 4, 2026 | K262130 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 25, 2026 | K260480 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 22, 2026 | K252887 | DePuy ATTUNE Knee System | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 15, 2026 | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | KWL | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 11, 2026 | K253624 | INHANCE Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 6, 2026 | K253551 | VELYS Hip Navigation | QIH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 19, 2025 | K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 23, 2025 | K251292 | RECLAIM Monobloc Revision Femoral Stem | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 22, 2025 | K243977 | EMPHASYS Acetabular System | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 23, 2024 | K243248 | INHANCE INTACT | PKC | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 21, 2024 | K242871 | ATTUNE Revision Hinge Knee | KRO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 1, 2024 | K242665 | DePuy ATTUNE Total Knee System | OIY | Substantially Equivalent | Depuy Orthopedics, Inc. | accessdata.fda.gov |
| July 11, 2024 | 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 | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 18, 2024 | K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 5, 2024 | K240211 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 4, 2024 | K240639 | PINNACLETM Constrained Acetabular Liners | KWZ | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 21, 2024 | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System | KRO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| February 15, 2024 | K231522 | EMPHASYS Dual Mobility System | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2024 | 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 | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 19, 2023 | K231526 | CORAIL Cemented Femoral Stem | KWY | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 14, 2023 | K233227 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 11, 2023 | K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 13, 2023 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 21, 2023 | K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| March 10, 2023 | K230295 | ATTUNE® Revision Cones | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 6, 2023 | K222296 | ARTICUL/EZE Ceramic Heads | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 2, 2022 | K223211 | INHANCETM Shoulder System Humeral Stems and Stemless | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 21, 2022 | K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 17, 2022 | K212746 | ATTUNE Revision Cones | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| September 15, 2022 | K220830 | TrueBalance Surgical System | ONN | Substantially Equivalent | These Three Medical, LLC | accessdata.fda.gov |
| September 6, 2022 | K221636 | EMPHASYS Acetabular System | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 31, 2022 | K221467 | INHANCETM Reverse Glenoid Peripheral Posts | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 22, 2022 | K220216 | C-Stem AMT LE Prosthesis | JDI | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 8, 2022 | K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | MBF | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 21, 2022 | K212737 | INHANCE Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System | PKC | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| January 18, 2022 | K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| September 15, 2021 | K212710 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 25, 2021 | K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| August 5, 2021 | K211657 | EMPHASYS Femoral Stems | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 22, 2021 | K203694 | DELTA XTEND Reverse Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 16, 2021 | K203108 | Ignite Stemless Anatomic Shoulder System | PKC | Substantially Equivalent | Ignite Orthopedics, LLC | accessdata.fda.gov |
| May 20, 2021 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | MEH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 20, 2021 | K202716 | Ignite Anatomic Shoulder System | MBF | Substantially Equivalent | Ignite Orthopedics, LLC | accessdata.fda.gov |
| April 28, 2021 | K203532 | BI-MENTUM ALTRX® Dual Mobility Liner | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| February 19, 2021 | K210167 | DELTA XTEND Reverse Shoulder System | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 14, 2021 | K202769 | VELYS Robotic-Assisted Solution | OLO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| December 28, 2020 | K202248 | Attune Revision Sleeve LPS Femoral Adaptors | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 25, 2020 | K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | MBH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 25, 2020 | K202098 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 19, 2020 | K203167 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 11, 2020 | K200854 | DePuy PINNACLE Dual Mobility Liner | LPH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 16, 2020 | K193549 | SIGMA High Performance (HP) Partial Knee System | HRY | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| February 24, 2020 | K192855 | DELTA XTEND(TM) Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| January 30, 2020 | K193057 | ATTUNE All-Polyethylene Tibia | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| November 26, 2019 | K192946 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 26, 2019 | K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 4, 2019 | K192448 | Delta Xtend Revers Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| May 17, 2019 | K183077 | Delta Xtend Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| January 11, 2018 | K170748 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 15, 2017 | K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| July 19, 2016 | K160907 | DePuy Actis DuoFix Hip Prosthesis | MEH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 25, 2015 | K150862 | DePuy Actis Duofox Hip Prosthesis | MEH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 3, 2014 | K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | KWS | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| June 11, 2012 | K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| December 15, 2010 | K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| November 23, 2010 | K102080 | DEPUY RECLAIM REVISION HIP SYSTEM | LZO | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| August 29, 2008 | K082239 | DEPUY C-STEM AMT | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 30, 2008 | K081620 | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 29, 2008 | K073676 | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 2, 2007 | K062250 | DELTA XTEND REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 6, 2005 | K052472 | DEPUY GLOBAL SHOULDER CROSSLINK GLENOID | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 22, 2004 | K042959 | DEPUY C-STEM AMT HIP PROSTHESIS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 7, 2001 | K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 5, 1998 | K982918 | DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 12, 1996 | K963309 | APEX HOLE ELIMINATOR PS | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| August 13, 1996 | K961939 | S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) | LPH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| July 12, 1996 | K961619 | DEPUY ENDURANCE CALCAR HIP PROSTHESIS | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| January 22, 1996 | K954935 | S-ROM FEMORAL HIP STEM - SIZE 14 X 8 | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| September 18, 1995 | K940743 | UHMWPE COMPONENTS-CHANGE IN PACKAGING | KWY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| June 3, 1994 | K934412 | COATED ZT PROXIMAL SLEEVE | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| April 1, 1992 | K910664 | MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. | LWJ | Substantially Equivalent | Medimix Products, Inc. | accessdata.fda.gov |
| April 8, 1988 | K871867 | ELITE MODULAR HIP SYSTEM | JDI | Substantially Equivalent | Thackray USA | accessdata.fda.gov |
| May 27, 1987 | K871510 | MODIFIED PROFILE HIP PMMA CEMENT SPACER | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| September 18, 1985 | K851422 | S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP | JDI | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| May 2, 1980 | K800894 | DUPUY CEMENT RESTRICTOR TRIALS & INSTR. | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 23, 2010 | P070026 | CERAMAX CERAMIC HIP SYSTEM | MRA | 121 | September 4, 2026 | accessdata.fda.gov |
| April 12, 1985 | P830055 | LCS(R) TOTAL KNEE SYSTEM | NJL | 355 | October 9, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2022 | 91261 | Class II | Ongoing | BIOSTOP 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.