# K210153: NextAR RSA Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 12, 2021 after 111 days
- Product code: SBF (Orthopedic Augmented Reality)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941847 (1994). 162 ancestors in all.
5 later devices descend from it; 4 cite it directly.
2 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173372: ExactechGPS Total Shoulder Application, Blue Ortho (2017) Summary page 1.
- K202152: NextAR TKA Platform, Medacta International S.A. (2020) Summary page 1.
- K193559: NextAR TKA Platform, Medacta Inernational SA (2020) Summary page 1.

## Most influential descendants
- K250108: OptiVu™ Shoulder (2025), 1 descendant of its own
- K232280: NextAR™ TSA Platform (2023), 1 descendant of its own
- K252847: NextAR Hip Platform (2026), 0 descendants of its own
- K251737: NextAR (TM) Shoulder Platform (2025), 0 descendants of its own
- K252170: OptiVu™ Shoulder (2025), 0 descendants of its own

## Recalls of this device
- Oct 27, 2022 · Class II · Z-0372-2023: A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fix

## Indications for use
The Shoulder NextAR™ RSA Platform supports the surgeon during glenoid implantation in reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The Shoulder NextAR™ RSA Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System Reverse (RSA – Reverse Shoulder Arthroplasty). As an optional display, the smart glasses can be used auxiliary to the Shoulder NextAR™ Platform to view the same 2D stereotaxic information as presented by the Shoulder NextAR™ Platform. The Shoulder NextAR™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical steps 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/K210153
Methodology: https://510kreport.com/methodology