Data / Medical devices / Ireland / Zimmer Orthopedic Mfg Ltd
Zimmer Orthopedic Mfg Ltd: FDA-registered device maker in Shannon Clare, Ireland, 13 510(k) clearances and 1 PMA approval
Zimmer Orthopedic Mfg Ltd is registered with the FDA (registration 3007963827) in Shannon Clare, Ireland. It lists 9 device types. The FDA files 13 510(k) clearances and 1 PMA approval under its listings, the newest dated September 5, 2019. 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
- 3007963827
- Address
- Building No 2 East Park Shannon Industrial Estate, Shannon Clare, Ireland, 0000000
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 6, 2007
- Registered through
- 2027
- Brand names listed
- NexGen Cruciate Retaining, NexGen Gender Sol. Female (GSF) Fem, NexGen LPS-Flex Mobile Bearing Knee, NexGen Legacy Posterior Stabilized, Next Generation Knee System, OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM, Persona Knee System-CPS, Persona Partial Knee System 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 5, 2019 | K191625 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 25, 2018 | K181947 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| May 17, 2018 | K172524 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 29, 2018 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| February 22, 2013 | K123459 | ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 5, 2012 | K122745 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| November 7, 2012 | K121771 | ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM | MBH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| March 27, 2012 | K113369 | ZIMMER PERSONA KNEE SYSTEM | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 28, 2006 | K060370 | NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 17, 2002 | K023211 | NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 30, 1999 | K991581 | NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| April 26, 1996 | K960279 | NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| January 30, 1995 | K933785 | NEXT GENERATION KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Zimmer, 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 10, 2007 | P060037 | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM | NJL | 98 | October 16, 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 |
|---|---|---|---|---|---|---|
| July 24, 2017 | 78960 | Class II | Terminated | NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty. | There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/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
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Updated October 16, 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.