# K021306: Vectorvision CT-Free Knee

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 25, 2002 after 184 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: 1 generation back to K010612 (2001). 1 ancestor in all.
387 later devices descend from it; 10 cite it directly.
0 of 389 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010612: Vectorvision Knee, Brainlab AG (2001) Summary page 1.

## Most influential descendants
- K040368: Vectorvision Hip 3.0 (2004), 180 descendants of its own
- K052213: Navigation SW Hip 3.1 on CI (2005), 170 descendants of its own
- K060468: Vectorvision Hip (2006), 154 descendants of its own
- K031196: Surgetics Ortho Kneelogics Navigation System (2005), 149 descendants of its own
- K060282: Total Knee Surgetics Navigation System (2006), 147 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 for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee endoprathesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Vectorvision@CT-free Knee. Example orthopedic surgical procedures include but are not limited to: Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking

Source page: https://510kreport.com/device/K021306
Methodology: https://510kreport.com/methodology