# K042513: Vectorvision Osteotomy

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Feb 10, 2005 after 148 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 K010612 (2001). 2 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 16 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.

## Most influential descendants
- K063028: Vectorvision Hip SR (2006), 11 descendants of its own
- K122011: Navigation Software Hip-Universal; Navigation Software Hip THR-Aesculap (2012), 5 descendants of its own
- K181449: Ortoma Treatment Solution - OTS (2018), 3 descendants of its own
- K232140: OTS Hip (2024), 2 descendants of its own
- K071929: Navitrack System- Partial Hip Resurfacing Universal (2007), 2 descendants of its own

## Indications for use
BrainLAB VectorVision is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated to assist a surgeon to perform one (open wedge) or two (closed wedge) cuts to achieve a leg angle correction. Example 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/K042513
Methodology: https://510kreport.com/methodology