Intellijoint Surgical Inc.
Kitchener Ontario, CA
Intellijoint Surgical Inc. appears in FDA device records in Kitchener Ontario, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Intellijoint Surgical Inc. between 2014 and 2021. The busiest year on record is 2017, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 3 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211876 | Intellijoint VIEW | LLZ | Substantially Equivalent | |
| K191507 | Intellijoint® Navigation System | OLO | Substantially Equivalent | |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | OLO | Substantially Equivalent | |
| K171525 | Intellijoint HIP Generation 2B System | OLO | Substantially Equivalent | |
| K162364 | Intellijoint HIP Generation 2A System | OLO | Substantially Equivalent | |
| K151364 | Intellijoint HIP(tm) System | OLO | Substantially Equivalent | |
| K133759 | INTELLIJOINT HIP | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010822102 | 3010822102 | Intellijoint Surgical Inc. | 809 Wellington St. N, Kitchener Ontario N2H 5L6 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1559-2020 | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. | Class II | Terminated | |
| Z-2228-2019 | Workstation, G2, Configured (P/N 000-0241) | 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 000-0241) in the Intellijoint HIP System. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain