# K053542: Surgetics Ortho Osteologics Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Praxim S.A
- Decided: Apr 10, 2006 after 111 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: 3 generations back to K010612 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K042513: Vectorvision Osteotomy, Brainlab AG (2005) Summary page 1.

## Indications for use
The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures. Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

Source page: https://510kreport.com/device/K053542
Methodology: https://510kreport.com/methodology