Data / Medical devices / Canada / Zimmer Cas
Zimmer Cas: FDA-registered device maker in Montreal, Quebec, Canada, 44 510(k) clearances
Zimmer Cas is registered with the FDA (registration 9617840) in Montreal, Quebec, Canada. It lists 24 device types. The FDA files 44 510(k) clearances under its listings, the newest dated June 4, 2026. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617840
- FEI number
- 3003714383
- Address
- 75 Queen ST., Suite 3300, Montreal, Quebec, Canada, H3C 2N6
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 20, 1999
- Registered through
- 2027
- Brand names listed
- CAS Fixation Pins, CAS PSI Knee System, CAS PSI Shoulder, ELIBRA DYNAMIC KNEE BALANCER, Efficient Care 3D Planning, HAMMR, Navitrack CT-Based, Navitrack CT-Free 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 |
|---|---|---|---|---|---|---|
| June 4, 2026 | K261510 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc. (d/b/a) Zimmer CAS | accessdata.fda.gov |
| May 21, 2026 | K260582 | ROSA® Shoulder System | OLO | Substantially Equivalent | Orthosoft Inc. (d/b/a) Zimmer CAS | accessdata.fda.gov |
| February 4, 2026 | K260104 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc. (d/b/a) Zimmer CAS | accessdata.fda.gov |
| November 13, 2025 | K251314 | Rosa® Knee System | OLO | Substantially Equivalent | Orthosoft Inc. (d/b/a) Zimmer CAS | accessdata.fda.gov |
| October 18, 2024 | K242864 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft Inc. (d/b/a) Zimmer CAS | accessdata.fda.gov |
| February 21, 2024 | K233199 | ROSA® Shoulder System | OLO | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| December 12, 2023 | K232425 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc. (D/B/A) Zimmer Cas) | accessdata.fda.gov |
| November 16, 2023 | K232533 | ROSA Partial Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| June 13, 2023 | K230567 | OptiVu ROSA® MxR | SBF | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| May 23, 2023 | K231162 | ROSA Hip System | LLZ | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| March 29, 2023 | K230243 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| February 22, 2023 | K230180 | Rosa Knee System | OLO | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| October 4, 2022 | K221928 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| July 29, 2022 | K220733 | OptiVu ROSA MxR | SBF | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| April 22, 2022 | K213708 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| January 14, 2022 | K213033 | iASSIST Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| October 12, 2021 | K212560 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| August 17, 2021 | K210998 | ROSA Hip System | LLZ | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| July 7, 2021 | K210653 | ONE Planner Hip | LLZ | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| April 19, 2021 | K210121 | ROSA Partial Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| June 5, 2020 | K200615 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| November 5, 2019 | K192080 | iASSIST Knee System | OLO | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| August 30, 2019 | K192074 | Signature ONE System | QHE | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| August 23, 2019 | K183544 | Efficient Care 3D Planning | LLZ | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| June 5, 2019 | K190595 | Signature ONE System | KWT | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| January 24, 2019 | K182964 | ROSA Knee System | OLO | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| December 28, 2017 | K171269 | X-PSI Knee System | JWH | Substantially Equivalent | Orthosoft Inc (D/B/A Zimmer Cas) | accessdata.fda.gov |
| June 16, 2015 | K150730 | Zimmer PSI Shoulder System | KWT | Substantially Equivalent | Zimmer | accessdata.fda.gov |
| September 11, 2014 | K141601 | IASSIST KNEE SYSTEM | OLO | Substantially Equivalent | Zimmer Cas | accessdata.fda.gov |
| September 13, 2013 | K131409 | CAS PSI KNEE SYSTEM | JWH | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| August 20, 2013 | K131129 | CAS PSI SHOULDER | KWS | Substantially Equivalent | Zimmer Cas | accessdata.fda.gov |
| November 30, 2012 | K122326 | SMARTTOOLS KNEE SYSTEM | OLO | Substantially Equivalent | Zimmer | accessdata.fda.gov |
| March 24, 2011 | K110054 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE | OLO | Substantially Equivalent | Zimmer Cas | accessdata.fda.gov |
| April 5, 2010 | K100599 | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | OLO | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| July 20, 2007 | K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| April 4, 2007 | K070108 | ELIBRA DYNAMIC KNEE BALANCER | ONN | Substantially Equivalent | Synvasive Technology, Inc. | accessdata.fda.gov |
| April 28, 2006 | K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| June 22, 2004 | K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| October 21, 2003 | K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| May 23, 2003 | K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| May 9, 2003 | K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| February 4, 2003 | K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| August 27, 2002 | K021760 | NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
| August 3, 2000 | K002053 | NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 | HAW | Substantially Equivalent | Orthosoft, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 7, 2022 | 89619 | Class II | Ongoing | NavitrackER Kit A: Knee, Model Number 20-8000-000-07 | The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention. | accessdata.fda.gov |
| February 20, 2017 | 76508 | Class II | Terminated | SmartTools Knee System Orthopedic Stereotaxic Instrument | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P | accessdata.fda.gov |
| April 19, 2015 | 71202 | Class II | Terminated | Tibial Alignment Guide; Orthopedic Stereotaxic Instrument | Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. | accessdata.fda.gov |
| November 3, 2014 | 69630 | Class II | Terminated | PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee repl | Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw. | accessdata.fda.gov |
| October 6, 2011 | 75614 | Class II | Terminated | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash. | accessdata.fda.gov |
| June 9, 2009 | 75615 | Class II | Terminated | NDI P7 Position Sensor, Stereotaxic Instrument | Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage. | accessdata.fda.gov |
| October 28, 2008 | 75613 | Class II | Terminated | Navitrack System - OS Knee Universal, Stereotaxic instrument | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies. | accessdata.fda.gov |
| June 20, 2008 | 75612 | Class III | Terminated | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3. | accessdata.fda.gov |
| June 4, 2008 | 75609 | Class II | Terminated | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central struc | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Knee Arthroplasty Implantation System
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of System, Image Processing, Radiological
- All makers of Orthopedic Augmented Reality
- All makers of Orthopedic Stereotaxic Instrument
Updated June 4, 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.