Navitrack System - Total Hip Replacement CT-Free
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032917 FDA 510(k)
- FDA Product Code
- HAW 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 Navitrack System - Total Hip Replacement CT-Free is a stereotaxic instrument intended to assist in the positioning of hip replacement components. It displays the position of components relative to the joint's alignment axes based on user-identified anatomy.
The device is supplied as a system for intra-operative use in orthopedic procedures. It received FDA 510(k) clearance (K032917) as substantially equivalent to a predicate device, with product code HAW and review advisory committee classification NE (Neurology).
Frequently asked questions
What is the Navitrack System - Total Hip Replacement CT-Free used for?
The Navitrack System - Total Hip Replacement CT-Free is a stereotaxic instrument intended to assist in the positioning of hip replacement components by displaying their position relative to the joint's alignment axes based on user-identified anatomy during orthopedic procedures.
How is the Navitrack System supplied and intended for use?
The device is supplied as a complete system for intra-operative use in orthopedic procedures, specifically designed to support surgeons during hip replacement surgery by providing real-time positional guidance of components.
Does the Navitrack System require CT imaging to function?
No, the Navitrack System is designed as a CT-free stereotaxic instrument, meaning it does not rely on preoperative CT scans; instead, it uses user-identified anatomy to determine and display component positioning relative to joint alignment axes.
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: Navitrack System - S&N Image Free Hip, Model Pro-03017, Navitrack System: Total Hip Replacement Ct-free Cup, Model 900.204, PDF 'JUN 2 2200435 - accessdata.fda.gov, NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | Orthosoft, Inc ..., Navitrack System - S&N Image Free Hip, Model Pro-03017
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032917 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthosoft Inc
- FDA Applicant
- Orthosoft, Inc.
Sources (1)
- FDA 510(k) K032917 24 fields · synced Oct 1, 2026