# K252847: NextAR Hip Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 9, 2026 after 123 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: 17 generations back to K905070 (1991). 228 ancestors in all.
No later device cites it as a predicate yet.
2 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243751: Mako Total Hip Application 5.0, Mako Surgical Corp. (2025) Summary page 5.
- K191507: Intellijoint® Navigation System, Intellijoint Surgical, Inc. (2019) Summary page 5.
- K210153: NextAR RSA Platform, Medacta International S.A. (2021) Summary page 5.
- K210859: NextAR™ Spine Platform, Medacta International S.A. (2021) Summary page 5.
- K193559: NextAR TKA Platform, Medacta Inernational SA (2020) Summary page 5.

## Indications for use
NextAR Hip is intended to support the surgeon during Total Hip Arthroplasty (THA) procedures by providing navigational information during bone preparation and positioning of acetabular cup components in skeletally mature individuals during supine or lateral approaches. NextAR Hip is indicated for use with Medacta hip prosthesis as described in the implants’ instruction for use. NextAR Hip provides stereotaxic guidance in reference to a patient’s rigid anatomy as registered in CT based or imageless workflows. As an optional display, the smart glasses can be used auxiliary to the NextAR Hip to view the same information as presented by the NextAR Hip. NextAR 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/K252847
Methodology: https://510kreport.com/methodology