# K220652: Knee 3

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 3, 2022 after 88 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: 7 generations back to K983831 (1999). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102990: Brainlab Knee, Brainlab AG (2011) Summary page 4.
- K080678: Uni-Knee 2.0, Brainlab AG (2008) Summary page 4.
- K102251: Dash Knee, Brainlab AG (2011) Summary page 4.

## Indications for use
Knee3 is intended to be an intraoperative localization system used during orthopedic knee surgery. It links a navigated instrument, tracked by a passive marker sensor system, to virtual computer image space on an individually acquired model of the patient's anatomical axes, which are generated through acquiring multiple anatomical bony landmarks. The system is indicated for medical conditions in which the use of stereotaxic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the femur and tibia, can be identified relative to the acquired anatomical landmarks. The system aids the surgeon to plan resections, measure cutting block alignment, measure bone resections, and/or leg alignment. The device is indicated for total and uni-compartmental knee replacement.

Source page: https://510kreport.com/device/K220652
Methodology: https://510kreport.com/methodology