# K102990: Brainlab Knee

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Apr 4, 2011 after 178 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K983831 (1999). 19 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073615: Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited, Brainlab AG (2008) Summary page 1.
- K061362: Pigalileo Total Knee Replacement (TKR) System, Plus Orthopedics AG (2006) Summary page 1.

## Most influential descendants
- 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
- K250086: OTS Hip (2025), 1 descendant of its own
- K261852: OTS Hip (2026), 0 descendants of its own

## Recalls of this device
- Oct 27, 2016 · Class II · Z-0959-2017: Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocess

## Indications for use
Brainlab Knee 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 prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Brainilb Knee. Example orthopedic surgical procedures include but are not limited to: * Total Knee Replacement * Ligament Balancing * Range of Motion Analysis * Patella Tracking

Source page: https://510kreport.com/device/K102990
Methodology: https://510kreport.com/methodology