# K213751: NextAR™ TKA Platform My Knee PPS

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 10, 2022 after 100 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: 12 generations back to K941847 (1994). 108 ancestors in all.
No later device cites it as a predicate yet.
2 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202152: NextAR TKA Platform, Medacta International S.A. (2020) Summary page 5.
- K193559: NextAR TKA Platform, Medacta Inernational SA (2020) Summary page 5.
- K170106: MyKnee PPS-Pin Positioners, Medacta International S.A. (2017) Summary page 6.

## Indications for use
The NextAR™ Knee 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™ Knee 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 MyKnee® PPS NextAR™ blocks include a PSI MyKnee® pin positioners block both for tibia and femur. The MyKnee® PPS NextAR™ blocks must be used as anatomical Pin positioners blocks 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 or MyKnee® PPS NextAR™ blocks are applicable only for the “PSI-based” approach. MyKnee® NextAR™ cutting guides or MyKnee® PPS NextAR™ blocks 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™ Knee stereotaxic instruments, when registered with the MyKnee® NextAR™ Knee 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/K213751
Methodology: https://510kreport.com/methodology