# K231284: OnPoint Augmented Reality Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Onpoint Surgical, Inc.
- Decided: Sep 8, 2023 after 128 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: 7 generations back to K050438 (2005). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220905: xvision Spine System, Augmedics, Ltd. (2022) Summary page 4.

## Most influential descendants
- K241870: OnPoint Augmented Reality Spine System (2024), 0 descendants of its own

## Indications for use
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy. The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location including deviation from plan. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

Source page: https://510kreport.com/device/K231284
Methodology: https://510kreport.com/methodology