Zimmer Orthopedics Manufacturing Limited-Galway

FDA Device Registration & Listing · Oranmore Galway, IE · Registration 3012319330

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012319330
FEI Number
3012319330
Entity Name
Zimmer Orthopedics Manufacturing Limited-Galway
City/State/Country
Oranmore Galway, IE
Establishment Address
Deerpark Industrial Estate, Oranmore Galway Galway, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ZIMMER, INC. (Owner Number: 1822565)
Owner / Operator Contact Address
345 E. Main Street, --, Warsaw, IN 46580, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243247
PMA Number
N/A

All Registered Proprietary Names

COMPREHENSIVE PRIMARY SHOULDER STEMS Comprehensive Shoulder System Persona Partial Knee System Zimmer Persona Personalized Knee System-Medial Congruent Persona™ Personalized Knee System Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces Zimmer Persona Knee System Persona OsseoTi 3-Peg Patella Persona Natural Tibia Baseplates Size J and Instrumentation Persona Knee System-CPS Persona Partial Knee Persona Personalized Knee System-PPS Zimmer Persona Personalized Knee System-Kinematic Alignment Persona the Personalized Knee System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2019-09-11
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2019-09-11
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2019-09-11
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2019-09-11
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-08-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-08-15
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2025-08-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2025-08-15
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2016-11-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-05-26
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2015-05-26
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2015-05-26
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-03-29
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2023-03-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-03-29
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2012-11-09
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2012-11-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-11-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-11-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-04-30
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2024-04-30
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-04-30
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2013-03-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-03-06
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-03-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-03-06
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2013-03-06
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2025-09-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-11-18
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-11-18
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-11-18
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2018-06-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-06-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-06-19
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2024-12-11
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-12-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Lynch Business: Zimmer Biomet Email: Stephanie.Lynch@zimmerbiomet.com Phone: (715) 9289253

Related Public Records

Same Entity

ZIMMER, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8031000 ZIMMER SURGICAL SA 1228 Plan Les Ouates Geneve, CH
3020393263 Zimmer U.S., Inc. Connected Health Grand Rapids, MI, US
1526350 ZIMMER SURGICAL, INC. Dover, OH, US
3005751028 Zimmer Trabecular Metal Technology, Inc. Parsippany, NJ, US
3012392319 Zimmer Biomet Canada DFE Mississauga Ontario, CA

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243247 Zimmer, Inc. Persona the Personalized Knee System 2024-10-29
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K033769 Howmedica Osteonics Corp. EIUS UNICOMPARTMENTAL KNEE SYSTEM 2004-02-13
K771511 3M Company TOTAL KNEE PROSTHESIS-NONCONSTRAINED 1977-11-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2019 Exactech, Inc. 2
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012319330. Last updated year: 2026. Please use registration number 3012319330 when referencing this establishment in official correspondence.
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