# K193559: NextAR TKA Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medacta Inernational SA
- Decided: Jul 10, 2020 after 200 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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: 10 generations back to K941847 (1994). 105 ancestors in all.
12 later devices descend from it; 6 cite it directly.
2 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083872: Imns Medacta Navigation System, Medacta International S.A. (2009) Summary page 4.
- K100314: Imns Medacta Navigation System,33.221000US, Medacta International S.A. (2010) Summary page 4.
- K093806: Myknee Cutting Blocks, Medacta International S.A. (2010) Summary page 4.
- K190929: xvision Spine system (XVS), Augmedics, Ltd. (2019) Summary page 4.

## Most influential descendants
- K202152: NextAR TKA Platform (2020), 11 descendants of its own
- K210153: NextAR RSA Platform (2021), 5 descendants of its own
- K210859: NextAR™ Spine Platform (2021), 4 descendants of its own
- K223769: NextAR™ Spine Platform (2023), 2 descendants of its own
- K250108: OptiVu™ Shoulder (2025), 1 descendant of its own

## Indications for use
The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR Platform to view the same 2D stereotaxic information as presented by the NextAR Platform. The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display. The MyKnee® NextAR cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® NextAR TKA cutting guides are for single use only. The NextAR™ stereotaxic instruments are intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the myKnee NextAR TKA cutting guides, provide reference to a patient’s rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning.

Source page: https://510kreport.com/device/K193559
Methodology: https://510kreport.com/methodology