# K031196: Surgetics Ortho Kneelogics Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Praxim
- Decided: Jun 7, 2005 after 783 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: 2 generations back to K002053 (2000). 5 ancestors in all.
149 later devices descend from it; 3 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021306: Vectorvision CT-Free Knee, Brainlab AG (2002) Summary page 1.
- K021760: Navitrack System-Optical TKR CT-Less, Model 900.120, Orthosoft, Inc. (2002) Summary page 1.

## Most influential descendants
- K060282: Total Knee Surgetics Navigation System (2006), 147 descendants of its own
- K062146: Uni Knee Surgetics Navigation System (2006), 99 descendants of its own
- 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

## Indications for use
The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during: * Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model * Total Knee Arthroplasty with ZIMMER NEXGEN implant * UniKnee Arthroplasty with BIOMET OXFORD Phase III implant

Source page: https://510kreport.com/device/K031196
Methodology: https://510kreport.com/methodology