Data / Medical devices / Canada / Intellijoint Surgical Inc.
Intellijoint Surgical Inc.: FDA-registered device maker in Kitchener Ontario, Canada, 5 510(k) clearances
Intellijoint Surgical Inc. is registered with the FDA (registration 3010822102) in Kitchener Ontario, Canada. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 12, 2021. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010822102
- Address
- 809 Wellington St. N Unit 2, Kitchener Ontario, Canada, N2H 5L6
- Owner or operator
- Intellijoint Surgical Inc. (10047431)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- August 29, 2014
- Registered through
- 2026
- Brand names listed
- Camera Drape, Intellijoint HIP, Intellijoint KNEE, Intellijoint Navigation System, Intellijoint VIEW, Passive Spheres(TM), intellijoint HIP(R)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Exporter to the US | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| November 12, 2021 | K211876 | Intellijoint VIEW | LLZ | Substantially Equivalent | Intellijoint Surgical, Inc. | accessdata.fda.gov |
| October 1, 2019 | K191507 | Intellijoint® Navigation System | OLO | Substantially Equivalent | Intellijoint Surgical, Inc. | accessdata.fda.gov |
| November 16, 2017 | K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | OLO | Substantially Equivalent | Intellijoint Surgical, Inc. | accessdata.fda.gov |
| January 27, 2004 | K033621 | NDI PASSIVE SPHERES | HAW | Substantially Equivalent | Northern Digital, Inc. | accessdata.fda.gov |
| August 13, 2002 | K022074 | SPHERZ | HAW | Substantially Equivalent | I.Z.I. Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 28, 2026 | 99821 | Class II | Ongoing | Intellijoint Navigation System: Workstation G2 Configured, REF:; Intellijoint HIP Cart System, REF:; Intellijoint HIP, Portable System, REF: | A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk. | accessdata.fda.gov |
| February 11, 2020 | 85016 | Class II | Terminated | Intellijoint Navigation System, Software Application, IJK1 (P/N ) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surg | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. | accessdata.fda.gov |
| June 28, 2019 | 83299 | Class II | Terminated | Workstation, G2, Configured (P/N ) | Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N ) in the Intellijoint HIP System. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Neurological Stereotaxic Instrument
- All makers of Drape, Surgical, Exempt
Updated October 7, 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.