# K052966: CI Knee, CI MI TKR

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Feb 13, 2006 after 115 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: 4 generations back to K983831 (1999). 8 ancestors in all.
54 later devices descend from it; 2 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)
- K021306: Vectorvision CT-Free Knee, Brainlab AG (2002) Summary page 1.
- K041899: Vectorvision Uni-Knee, Brainlab AG (2004) Summary page 1.
- K031770: CI TKR/Ukr, Brainlab AG (2003) Summary page 1.

## Most influential descendants
- K073615: Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited (2008), 52 descendants of its own
- K091411: Kneealign System (2009), 41 descendants of its own
- K093998: Kneealign System with Reference Sensor (2010), 40 descendants of its own
- K103829: Kneealign System (2011), 39 descendants of its own
- K130387: Orthoalign Plus System (2013), 31 descendants of its own

## Indications for use
Ci TKR/UKR 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 31model 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 stereo tactic 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 Ci TKR/UKR. 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/K052966
Methodology: https://510kreport.com/methodology