# K250477: NextAR (TM) Spine

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 31, 2025 after 162 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: 15 generations back to K941847 (1994). 110 ancestors in all.
No later device cites it as a predicate yet.
2 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233172: NextAR™ Spine Platform, Medacta International S.A. (2024) Summary page 6.
- K210859: NextAR™ Spine Platform, Medacta International S.A. (2021) Summary page 6.

## Indications for use
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as: • Pedicle Screw Placement (Thoracic and Lumbosacral spine) • Sacro-Iliac Screw Placement NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine. The NextAR Spine platform is intended to be used in combination with NextAR TM Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display. The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.

Source page: https://510kreport.com/device/K250477
Methodology: https://510kreport.com/methodology