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Sign in to claim this brandIntellijoint Surgical Inc
US
Last updated May 24, 2026
What Intellijoint Surgical Inc makes
Intellijoint Surgical Inc manufactures orthopaedic stereotactic surgery systems, including devices specifically designed for hip and knee procedures. These systems are intended to assist in precise surgical planning and execution for joint replacements, ensuring alignment and positioning accuracy during procedures.
The company’s portfolio is regulated under Class II medical devices in the US, with devices listed via FDA 510(k) and FDA UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Intellijoint Surgical Inc manufacture?
Intellijoint Surgical Inc specializes in orthopaedic stereotactic surgery systems, specifically designed for hip and knee procedures. These systems are used to enhance precision during joint replacement surgeries by aiding in surgical planning and ensuring accurate alignment and positioning of implants.
Where is Intellijoint Surgical Inc based?
Intellijoint Surgical Inc is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in the US market.
How are Intellijoint Surgical Inc’s devices classified in the US?
Intellijoint Surgical Inc’s devices fall under Class II classification in the US. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls to ensure safety and effectiveness beyond general controls, such as FDA 510(k) premarket notifications.
Which regulatory registries list Intellijoint Surgical Inc’s devices?
Intellijoint Surgical Inc’s devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identification (UDI) system. The 510(k) process ensures these devices meet regulatory requirements for marketing in the US, while the UDI system helps track and trace devices throughout their lifecycle for better patient safety and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- intellijointsurgical.com
- —
- —
- [email protected]
- Phone
- 15193423178
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 202958070
Catalogue (84)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| intellijoint KNEE® | 000-0521 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0401 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0285 | FDA UDI | Class II | Active |
| intellijoint KNEE® | 000-0519 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0214 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0189 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0387 | FDA UDI | Class II | Active |
| intellijoint HIP (R) | 000-0811 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0210 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0247 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0377 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0282 | FDA UDI | Class II | Active |
| intellijoint KNEE® | 000-0559 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0270 | FDA UDI | Class II | Unknown |
| intellijoint HIP® | 000-0358 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0172 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0159 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0300 | FDA UDI | Class II | Active |
| intellijoint KNEE® | 000-0551 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0368 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0250 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0284 | FDA UDI | Class II | Active |
| intellijoint HIP® | 000-0234 | FDA UDI | Class II | Active |
| intellijoint HIP (R) | 000-0800 | FDA UDI | Class II | Active |
| intellijoint KNEE® | 000-0550 | FDA UDI | Class II | Active |
| intellijoint KNEE® | 000-0566 | FDA UDI | Class II | Active |
| intellijoint KNEE® | 000-0536 | FDA UDI | Class II | Active |
| Intellijoint HIP Generation 2A System | K162364 | FDA 510(k) | Class II | Active |
| Intellijoint VIEW | K211876 | FDA 510(k) | Class II | Active |
| Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | K172849 | FDA 510(k) | Class II | Active |
| Intellijoint® Navigation System | K191507 | FDA 510(k) | Class II | Active |
| Intellijoint HIP Generation 2B System | K171525 | FDA 510(k) | Class II | Active |
| Intellijoint Hip | K133759 | FDA 510(k) | Class II | Active |
| Intellijoint HIP(tm) System | K151364 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Intellijoint Surgical Inc. has two FDA recall records, both initiated in 2019 and 2020, with the earliest on June 28, 2019, and the most recent on February 11, 2020. Both records are marked as terminated. One recall pertains to potential incorrect femur resection depth calculations in the software used during total knee arthroplasty (TKA). The other involves the distribution of 15-inch MacBook Pro workstations (affected part number 000-0241) in the Intellijoint HIP System, where the battery may overheat and pose a fire safety risk.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 11, 2020 | Z-1559-2020 | — | terminated | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. |
| Jun 28, 2019 | Z-2228-2019 | — | terminated | 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. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Intellijoint Surgical Inc. Kitchener Ontario · CA FEI 3010822102