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Knee 3

Brainlab AG

Country / Region:Germany (DE)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Germany (DE)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K220652
Device name
Knee 3
Country / Region
Germany(DE)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-03-07
Decision date
2022-06-03
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Knee SurgeryNavigation System
Primary application
Knee Surgery
Classification source
AI classified

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.

Intended 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.

Device Description

The Knee3 is a software application module intended to be used on compatible navigation platforms that assist in the implantation of prosthetic knee implants. It uses instruments and accessories such as reference arrays, pointers and plane tools, which are tracked by an infrared camera of the respective platform, to determine femur and tibia anatomical landmarks as well as instrument positions in relation to the registered bones. The resulting navigation measurements support the user with the placement of the cutting guides. Tracking is based on infrared passive and active marker based tracking as provided by the optical tracking camera unit of the navigation station. The relation between the patient and the reference attached to the patient is realized with a manual registration using instruments. The Knee3 software receives position and orientation of tracked instrument accessories and calculates the navigation measurements out of their relations to each other. The measurement values are displayed within the software graphical user interface on the respective platform screen. The display features an LCD display with capacitive dual touch technology.

Summary parsed at:2026-06-24 04:32:47 UTC

Predicate devices

3

K220652 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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