Identifiers
- 510(k) Number
- K151364 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Intellijoint HIP System is a surgical navigation device designed to assist with total hip replacement procedures. It provides real-time intraoperative guidance to help surgeons optimize implant positioning during hip arthroplasty.
The system is supplied as a sterile, single-use device and is not intended for MRI environments. It is authorized under FDA 510K clearance with product code OLO and model number K151364. The device should be stored according to the manufacturer's instructions and requires proper training for effective use.
Frequently asked questions
What is the Intellijoint HIP System used for?
The Intellijoint HIP System is a surgical navigation device designed to assist with total hip replacement procedures. It provides real-time intraoperative guidance to help surgeons optimize implant positioning during hip arthroplasty.
How is the Intellijoint HIP System supplied?
The system is supplied as a sterile, single-use device and is not intended for MRI environments. It requires proper training for effective use and should be stored according to the manufacturer's instructions.
What is the regulatory status of the Intellijoint HIP System?
The Intellijoint HIP System is authorized under FDA 510K clearance with product code OLO and model number K151364. It was determined to be substantially equivalent through a traditional clearance process.
Is the Intellijoint HIP System reusable?
No, the Intellijoint HIP System is supplied as a sterile, single-use device and is not intended for reuse. Each unit should be discarded after a single surgical procedure to maintain sterility and ensure proper functioning.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151364 | Class II | Active |
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Manufacturer
- Manufacturer
- Intellijoint Surgical Inc
- FDA Applicant
- Intellijoint Surgical, Inc.
Sources (1)
- FDA 510(k) K151364 24 fields · synced Sep 23, 2026