# K071929: Navitrack System- Partial Hip Resurfacing Universal

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft, Inc.
- Decided: Sep 19, 2007 after 68 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002053 (2000). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063028: Vectorvision Hip SR, Brainlab AG (2006) Summary page 1.
- K032917: Navitrack System - Total Hip Replacement CT-Free, Orthosoft, Inc. (2003) Summary page 1.
- K060336: Navitrack System-OS Knee Universal, Model Pro-05002, Orthosoft, Inc. (2006) Summary page 1.

## Most influential descendants
- K100599: Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton Pin 3.2 Dia X 150 MM (2010), 1 descendant of its own
- K131130: Navigation Pin (2013), 0 descendants of its own

## Recalls of this device
- Nov 2, 2009 · Not classified · Z-0558-2010: The power cord female receptacle is not recessed sufficiently and may present a shock hazard.
- Jun 9, 2009 · Class II · Z-2048-2017: Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determ
- Jun 4, 2008 · Class II · Z-2227-2017: Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

## Indications for use
The Navitrack® Partial Hip Resurfacing - Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

Source page: https://510kreport.com/device/K071929
Methodology: https://510kreport.com/methodology