# K251737: NextAR (TM) Shoulder Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 4, 2025 after 90 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: 16 generations back to K911686 (1991). 229 ancestors in all.
No later device cites it as a predicate yet.
3 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232280: NextAR™ TSA Platform, Medacta International S.A. (2023) Summary page 5.
- K210153: NextAR RSA Platform, Medacta International S.A. (2021) Summary page 5.
- K231911: Glenoid Reconstruction System – Full Wedge Baseplate, Medacta International S.A. (2023) Summary page 5.
- K213459: Glenoid Reconstruction System, Medacta International S.A. (2022) Summary page 5.
- K193559: NextAR TKA Platform, Medacta Inernational SA (2020) Summary page 5.
- K170452: Medacta Shoulder System, Medacta International S.A. (2017) Summary page 5.

## Indications for use
The NextAR Shoulder ™ Platform supports the surgeon during glenoid implantation in anatomic and reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The NextAR Shoulder ™ Platform works in conjunction with NextAR ™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System shoulder prosthesis. As an optional display, the smart glasses can be used auxiliary to the NextAR Shoulder ™ Platform to view the same 20 stereotaxic information as presented by the NextAR Shoulder ™ Platform. The NextAR Shoulder ™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical procedures by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR ™ stereotaxic instruments provide reference to a patient's rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning. The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display

Source page: https://510kreport.com/device/K251737
Methodology: https://510kreport.com/methodology