Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617840

FEI Number

3003714383

Entity Name

ZIMMER CAS

City/State/Country

MONTREAL, QUEBEC, CA

Establishment Address

75 QUEEN ST., SUITE 3300, MONTREAL, QUEBEC H3C 2N6, CA

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

Expiration Date (Year)

2026

510(k) Number

K150730

PMA Number

N/A

All Registered Proprietary Names

CAS PSI Knee System Zimmer PSI Knee Signature ONE System Rosa Knee System OptiVu ROSA® Mixed Reality OptiVu ROSA® MxR ROSA Shoulder System X-Ray Calibration Strap Long and Short Signature ONE System-Shoulder Signature ONE System X-PSI Knee System Signature ONE System ELIBRA DYNAMIC KNEE BALANCER Efficient Care 3D Planning ROSA® Hip System Zimmer Biomet X Series HAMMR Navitrack CT-Free Navitrack OS Knee Universal X-Ray Marker Navitrack S&N Image Free Hip Navitrack-CT Free Cup ROSA Shoulder System Navitrack Optical TKR CT-Less ONE Planner Hip OptiVu ROSA® MxR ROSA Hip System Navitrack-FluoroSpine ROSA® Knee System CAS Fixation Pins Navitrack OS Unicond Knee Universal Zimmer PSI Shoulder CAS PSI Shoulder Signature ONE System iASSIST Knee System Navitrack CT-Based ROSA® Knee System iASSIST Knee System ROSA Knee System PSN Valgus Alignment Guide ROSA Knee System Navitrack-Optical Option iASSIST Knee System Signature ONE System Zimmer PSI Shoulder System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-10-21
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2013-10-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-10-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2021-10-19
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2021-10-19
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-10-19
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2021-10-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-10-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-11-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-08-02
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2022-08-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-02-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-02-22
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2018-12-07
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2020-06-08
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-06-08
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-06-08
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-06-08
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-06-08
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2026-06-05
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2026-06-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2026-06-05
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2026-06-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-06-05
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2026-06-05
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-04-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-04-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-04-10
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2018-04-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-12-14
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-12-14
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2023-12-14
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2023-12-14
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-12-14
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-12-14
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	Class 2	882.4560	2012-02-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-08-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-05-24
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2011-04-19
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2011-04-05
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2018-12-07
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-05-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-05-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2021-07-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-07-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-07-09
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-07-09
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2023-06-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-06-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-08-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-08-18
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-03-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2010-12-07
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2013-09-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-09-16
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2020-09-04
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-09-04
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-09-04
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-09-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-09-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-09
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-02-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-02-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1999-05-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-22
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2008-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-01-19
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2026-02-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2026-02-05
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2026-02-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-02-05
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2026-02-05
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2026-02-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2015-06-18
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2015-06-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-06-18

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
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617840. Last updated year: 2026. Please use registration number 9617840 when referencing this establishment in official correspondence.