Intellijoint HIP Generation 2B System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171525 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 Generation 2B 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. It is a surgeon-controlled navigation tool for total hip arthroplasty (THA) that provides real-time, intraoperative measurements for fast, easy and accurate implant alignment for cup position, leg length and offset.
The device is supplied as a system for use in the operating room during total hip arthroplasty procedures. It is not described as sterile, single-use, or reusable in the provided data, and no information is given regarding MRI safety, sizes, storage conditions, or specific authorisations beyond the FDA 510(k) clearance under K171525.
Frequently asked questions
What is the Intellijoint HIP Generation 2B System used for?
The Intellijoint HIP Generation 2B 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 during total hip arthroplasty, where a reference to a rigid anatomical structure can be identified.
How is the Intellijoint HIP Generation 2B System supplied for use in surgery?
The device is supplied as a system for use in the operating room during total hip arthroplasty procedures, as stated in the device description, with no indication of sterility, single-use, or reusable designation provided in the data.
Does the Intellijoint HIP Generation 2B System provide measurements for leg length and offset during hip replacement surgery?
Yes, the system provides real-time, intraoperative measurements for fast, easy and accurate implant alignment for cup position, leg length and offset, as explicitly stated in the description of its function during total hip arthroplasty.
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. Sources consulted: Intellijoint HIP® - Intellijoint Surgical, Home - Intellijoint Surgical, Intellijoint HIP Generation 2B System (K171525) — FDA 510(k ..., Intellijoint HIP Generation 2B System 510 (k) K171525 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171525 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intellijoint Surgical Inc
- FDA Applicant
- Intellijoint Surgical, Inc.
Sources (1)
- FDA 510(k) K171525 24 fields · synced Sep 27, 2026