# K063408: Ctlogics Navigations Systems

- Pathway: 510(k) (Traditional)
- Applicant: Praxim Medivision, SA
- Decided: Feb 28, 2007 after 107 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: 5 generations back to K002053 (2000). 17 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053159: Vectorvision Spine, Brainlab AG (2006) Summary page 1.
- K062146: Uni Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.
- K022239: Surgetics Entact Endonasal Navigation System, Praxim (2002) Summary page 1.

## Most influential descendants
- K081232: Total Knee Surgetics Navigation System with Praxiteles (2008), 18 descendants of its own
- K090953: Total Knee Surgetics Navigation System with Iblock (2010), 17 descendants of its own
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2017), 15 descendants of its own
- K173372: ExactechGPS Total Shoulder Application (2017), 14 descendants of its own
- K163338: OMNIBotics Knee System (2017), 12 descendants of its own

## Indications for use
The CTLOGICS Navigation System is an optically based surgical navigation system. It is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures. The system which uses patient's preoperative image data is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone, or a vertebra can be identified relative to CT-based model of the anatomical structure. Example procedures include but are not limited to: Posterior spinal implant procedures such as pedicle screw placement, kyphoplasty and vertebroplasty procedures, thoracic spine surgery, tumor surgery on the spinal column. Superolateral and deltopectoral shoulder procedures, such as guiding the glenoid component on the scapula.

Source page: https://510kreport.com/device/K063408
Methodology: https://510kreport.com/methodology