# K202152: NextAR TKA Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Oct 27, 2020 after 85 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: 11 generations back to K941847 (1994). 106 ancestors in all.
11 later devices descend from it; 3 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)
- K193559: NextAR TKA Platform, Medacta Inernational SA (2020) Summary page 4.

## Most influential descendants
- 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
- K233172: NextAR™ Spine Platform (2024), 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 behaviour, instruments and implants positioning. The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments 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. The use of MyKnee® NextAR™ cutting guides are applicable only for the “PSI-based” approach. 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/K202152
Methodology: https://510kreport.com/methodology