APS MATERIALS INC. IRELAND

FDA Device Registration & Listing · Waterford, IE · Registration 3007740680

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
3007740680
FEI Number
3007740680
Entity Name
APS MATERIALS INC. IRELAND
City/State/Country
Waterford, IE
Establishment Address
Unit 26A, Waterford Industrial Estate, Cork Road, Waterford, Waterford N/A, IE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
APS Materials Inc. Ireland (Owner Number: 10029870)
Owner / Operator Contact Address
Unit 26A, Waterford Industrial Estate, Cork Road, Waterford, Waterford, IE-WD X91F670, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INBONE TOTAL ANKLE Comprehensive Shoulder System Latitude EV Total Elbow Arthroplasty Latitude EV Total Elbow Arthroplasty Aequalis Reversed Shoulder Prosthesis INBONE II TOTAL ANKLE REPLACEMENT PERFORM Humeral System - Stem Comprehensive Reverse Shoulder System Topez Total Ankle Replacement

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2023-10-24
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2025-08-19
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2023-08-23
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2023-08-23
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2011-03-02
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-11-16
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2023-11-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-11-16
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-11-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-11-16
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2023-11-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-11-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-11-16
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2023-11-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-11-16
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2023-11-16
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2023-11-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-11-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-11-16
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-11-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-11-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-10
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-10
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-10
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2011-03-02
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2023-08-23
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2023-08-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-08-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-08-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-10
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2023-10-24
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-08-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2023-08-23
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2023-08-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-08-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2023-08-23
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2026-06-08
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-06-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2026-06-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-06-08
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2026-06-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-06-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2011-03-02
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2023-11-07

Official Correspondent

John Day

US Agent Details

Christopher L. Page Email: chrisp@apsmaterials.com Phone: (937) 2786547

Related Public Records

Same Entity

APS Materials Inc. Ireland
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K983036 Biomet, Inc. SINGLE AXLE TOTAL ELBOW 1999-04-30
K040389 Zimmer, Inc. COONRAD/MORREY ELBOW CEMENT RESTRICTOR 2004-05-17
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2022 Exactech, Inc. 2
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0032-2009 Biomet, Inc. 2
Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009 Biomet, Inc. 2
Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007740680. Last updated year: 2026. Please use registration number 3007740680 when referencing this establishment in official correspondence.
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