# K093118: Brainlab Knee Arthroscopy

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 11, 2010 after 252 days
- Product code: OLO (Orthopedic 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: 6 generations back to K983831 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042512: Vectorvision Acl, Brainlab AG (2005) Summary page 1.
- K073615: Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited, Brainlab AG (2008) Summary page 1.

## Indications for use
BrainLAB AOL is intended to be used as an intraoperative image-guided navigation system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system, to a virtual computer image space on the model of a bone, overlaid with individually acquired patient landmarks. The system is indicated for any surgical anterior cruciate ligament procedure in which the use of stereotactic surgery for the planning and navigation of interosseous canals may be appropriate, and where a reference to a rigid anatomical structure can be established.

Source page: https://510kreport.com/device/K093118
Methodology: https://510kreport.com/methodology