# K042512: Vectorvision Acl

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jan 13, 2005 after 120 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 K983831 (1999). 5 ancestors in all.
57 later devices descend from it; 4 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012448: Vectorvision Trauma, Brainlab AG (2002)
- K021306: Vectorvision CT-Free Knee, Brainlab AG (2002) Summary page 2.

## Most influential descendants
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90) (2008), 53 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K100931: Mylabtwice, Model 6200 (2010), 46 descendants of its own
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own

## Indications for use
BrainLAB VectorVision ACL is intended to be an intra-operative 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 a patient's intra-operative image data which is processed by a VectorVision workstation. A virtual individual 3D-surface model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface, supplements the 2D information of the intra-operative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a bone structure, such as tibia and femur, can be identified relative to a CT, fluoroscopic, x-ray or MR-based model of the anatomy. An example procedure includes but is not limited to: Planning and drill-tunnel guidance of interosseous canals for ligament repair on the knee.

Source page: https://510kreport.com/device/K042512
Methodology: https://510kreport.com/methodology