Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009555440

FEI Number

3009555440

Entity Name

Materialise Ukraine, Rep. office

City/State/Country

Kyiv Kyyiv, Misto, UA

Establishment Address

Raisy Okipnoy str., 8A, Kyiv Kyyiv, Misto 02002, UA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MATERIALISE N.V. (Owner Number: 9029485)

Owner / Operator Contact Address

Technologielaan 15, --, Leuven, BE-NOTA 3001, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172650

PMA Number

N/A

All Registered Proprietary Names

TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Titanium 3D Printed Implant System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner BKS Total PSI Signature Guides Materialise TKA Guide System Materialise TKA Guides and Models Zimmer Biomet Patient Specific Instruments Materialise TKA Guide Planner SurgiCase Knee Planner Materialise Knee Guide System Zimmer Patient Specific Instruments Materialise SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise Knee Planner Lima Personalized Surgical Instruments Materialise Knee Platform Signature Planner SurgiCase Planner Materialise Glenoid Positioning System guides Lima Personalized Surgical Instruments Match Point System Materialise SurgiCase Planner SurgiCase Shoulder Planner AtlasPlan Shoulder System Materialise Glenoid Positioning System Match Point System guides TruMatch Personalized Solutions Shoulder Guide Materialise Shoulder Planner Materialise Shoulder Guide and Models Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System guides TruMatch Personalized Solutions Shoulder Guide AtlasPlan Shoulder System SurgiCase Shoulder Planner Materialise Shoulder Planner Materialise SurgiCase Planner Materialise Glenoid Positioning System SurgiCase Planner Materialise Shoulder System Match Point System ProPlan CMF Models CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides Materialise Shoulder System Materialise Shoulder Guide and Models Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System AtlasPlan Shoulder System TruMatch Personalized Solutions Shoulder Guide Match Point System guides Lima Personalized Surgical Instruments SurgiCase Shoulder Planner Materialise Glenoid Positioning System guides SurgiCase Planner Materialise Glenoid Positioning System Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Materialise PKA Guides Materialise PKA Models SurgiCase Knee Planner Zimmer Biomet Patient Specific Instruments Materialise PKA Guide System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System TruMatch CMF Titanium 3D Printed Implant System TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants Materialise SurgiCase Planner TruMatch Personalized Solutions Shoulder Guide Materialise Glenoid Positioning System Materialise Shoulder Guide and Models Lima Personalized Surgical Instruments SurgiCase Planner AtlasPlan Shoulder System Materialise Shoulder System Materialise Shoulder Planner Match Point System SurgiCase Shoulder Planner Match Point System guides Materialise Glenoid Positioning System guides Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System Match Point System Materialise Shoulder Planner Lima Personalized Surgical Instruments Materialise SurgiCase Planner Match Point System guides Materialise Glenoid Positioning System TruMatch Personalized Solutions Shoulder Guide SurgiCase Shoulder Planner SurgiCase Planner TruMatch Personalized Solutions Shoulder System Materialise Glenoid Positioning System guides Mimics Medical Mimics Automatic Algorithms Knee CT Mimics Automatic Algorithms CMF CT Mimics Automatic Algorithms Knee MRI Mimics Automatic Algorithms Heart CT Mimics Plugin Segment Thin Bone HeartPrint Mimics Plugin Compare Masks Mimics Plugin RT Plugin Mimics Automatic Algorithms Torso Bones CT Mimics Automatic Algorithms Ankle CT Materialise Shoulder Planner Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System Match Point System guides SurgiCase Shoulder Planner Materialise SurgiCase Planner Materialise Glenoid Positioning System SurgiCase Planner SurgiCase Guide SurgiCase Connect SurgiCase Orthopaedics System TruMatch Personalized Solutions Shoulder Guide Materialise Glenoid Positioning System Lima Personalized Surgical Instruments Materialise Shoulder Planner Match Point System Materialise Glenoid Positioning System guides SurgiCase Shoulder Planner Match Point System guides Materialise Shoulder Guide and Models AtlasPlan Shoulder System Materialise SurgiCase Planner Materialise Shoulder System SurgiCase Planner Mimics Medical Mimics inPrint Mimics MatchPoint System TM Guides SurgiCase Connect MatchPoint System TM Materialise PKA Guides Materialise PKA Guide System Zimmer Patient Specific Instruments Signature Guides SurgiCase Knee Planner Zimmer Biomet Patient Specific Instruments Zimmer Patient Specific Instruments Planner Signature Planner Materialise SurgiCase Knee Planner Materialise TKA Guides Lima PSI Materialise Knee Guides Materialise TKA Guide planner Materialise SurgiCase Knee Module Materialise Knee Guide System Materialise Knee Planner Materialise Knee Guide planner SurgiCase Knee Planner Materialise Knee Platform Materialise TKA Guide System Materialise TKA Guide System Materialise TKA Guides SurgiCase Knee Planner Materialise SurgiCase Knee Module Materialise Knee Planner Materialise Knee Guides Materialise Knee Guide planner Materialise Knee Platform Bespoke PSI Materialise Knee Guide System Materialise TKA Guide planner Bespoke Patient Specific Instruments Materialise SurgiCase Knee Planner Signature Guides Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise SurgiCase Knee Planner BKS Total PSI Lima Personalized Surgical Instruments Materialise TKA Guides and Models SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Signature Planner Materialise TKA Guide System Zimmer Biomet Patient Specific Instruments Zimmer Patient Specific Instruments Materialise Knee Guide System Materialise TKA Guide Planner Materialise Knee Platform Materialise Knee Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System Materialise Eyewear Fitting Suite Signature Personalized Patient Care System Signature Planner Signature Guide Signature Personalized Patient Care System Signature Planner Signature Guide Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner Mimics Enlight Materialise Mimics Enlight SurgiCase Shoulder Planner Lima Personalized Surgical Instruments Match Point System Materialise Glenoid Positioning System guides Materialise Shoulder Planner Match Point System guides Materialise SurgiCase Planner Materialise Glenoid Positioning System SurgiCase Online Management System Zimmer Patient Specific Instruments Online Management System SurgiCase Transfer SurgiCase OOS SurgiCase Online Signature Online Management System SurgiCase Drive SurgiCase Mobile ProPlan CMF Online Lima Personalized Surgical Instruments TruMatch Personalized Solutions Shoulder Guide SurgiCase Planner TruMatch Personalized Solutions Shoulder System Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System Materialise Glenoid Positioning System Match Point System guides Materialise Glenoid Positioning System guides SurgiCase Shoulder Planner Materialise TKA Guide System Materialise Knee Guide System Signature Guides Lima Personalized Surgical Instruments SurgiCase Knee Planner Materialise SurgiCase Knee Planner Materialise TKA Guides Materialise Knee Platform Zimmer Patient Specific Instruments Planner Materialise TKA Guides and Models Materialise Knee Guides Materialise Knee Planner Signature Planner BKS Total PSI Materialise TKA Guide Planner Zimmer Biomet Patient Specific Instruments Materialise SurgiCase Knee Module Zimmer Patient Specific Instruments SurgiCase Planner Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System Match Point System guides Materialise Shoulder Planner Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise Glenoid Positioning System TruMatch Personalized Solutions Shoulder Guide AtlasPlan Shoulder System Materialise Shoulder System Materialise SurgiCase Planner Mimics Viewer XR Viewer SurgiCase Viewer SurgiCase Orthopaedics SurgiCase Guide SurgiCase Connect Materialise SurgiCase Knee Module Materialise SurgiCase Knee Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Materialise TKA Guides Signature Planner Materialise TKA Guide System Materialise Knee Planner Signature Guides Materialise Knee Guides Materialise Knee Platform Materialise TKA Guide planner SurgiCase Knee Planner Materialise SurgiCase Knee Module Materialise SurgiCase Knee Planner Materialise Knee Planner Materialise Knee Guides Materialise PKA Guides Materialise Knee Guide System SurgiCase Knee Planner Materialise PKA Guide planner Materialise Knee Guide planner Materialise Knee Platform Materialise PKA Guide System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-08-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-11-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2009-11-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2026-03-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-03-03
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2026-03-03
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2026-03-03
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2022-02-04
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-02-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-02-04
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-12-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-03
PPT	Cranial Surgical Planning And Instrument Guides	Neurology	Class 2	882.4310	2026-01-30
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-18
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-06-18
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-06-06
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-06-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-06-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-06-06
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2020-12-10
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-12-10
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-03-18
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-03-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-03-18
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-03-18
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-09-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-09-27
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-09-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-09-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-04-11
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-04-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2012-04-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-12-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-05-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-06-28
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2017-02-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-11-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-11-30
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-11-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-04-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-11-07
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2018-07-13
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2018-07-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-11-28
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-11-28
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-11-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2016-11-28
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-08-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2015-08-19
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2015-08-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-08-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-07-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-07-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-07-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2022-07-26
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2012-01-24
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-01-24
HMM	Distometer	Ophthalmic	Class 1	886.1190	2023-11-30
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2011-02-09
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-02-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-02-09
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-02-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-26
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2011-05-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2011-05-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-05-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-05-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-12-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-07-09
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-07-06
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-12-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-07-17
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-09-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2025-09-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-09-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-09-25
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-09-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-09-15
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2022-09-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-08-22
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2014-04-23
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2018-03-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-03-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-03-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-03-26
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2017-12-04
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2017-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

Jenny Jones Business: Materialise USA Email: jenny.jones@materialise.com Phone: (734) 2597017

Related Public Records

Same Entity

MATERIALISE N.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026963399	Materialise S.A.	Bielany Wroclawskie Dolnoslaskie, PL
3006543248	Materialise Motion N.V.	Paal Limburg, BE
3003998208	MATERIALISE N.V.	LEUVEN Vlaams Brabant, BE
3011724582	Materialise Colombia S.A.S	Medellin Antioquia, CO
3005718816	Materialise USA, LLC.	Plymouth, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009555440. Last updated year: 2026. Please use registration number 3009555440 when referencing this establishment in official correspondence.