# K062146: Uni Knee Surgetics Navigation System

- Pathway: 510(k) (Special)
- Applicant: Praxim S.A
- Decided: Aug 21, 2006 after 25 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002053 (2000). 7 ancestors in all.
99 later devices descend from it; 3 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031196: Surgetics Ortho Kneelogics Navigation System, Praxim (2005) Summary page 1.
- K060282: Total Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.

## Most influential descendants
- K071714: Navitrack System - OS Unicondylar Knee Universal, Model#  Pro-06003 (2007), 79 descendants of its own
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), 76 descendants of its own
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System (2012), 46 descendants of its own
- K143752: Total Knee Application (TKA) (2015), 44 descendants of its own

## Indications for use
The UNI KNEE SURGETICS Navigation System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: UniKnee Arthroplasty

Source page: https://510kreport.com/device/K062146
Methodology: https://510kreport.com/methodology