# K202487: HealthJOINT

- Pathway: 510(k) (Traditional)
- Applicant: Zebra Medical Vision, Ltd.
- Decided: Dec 4, 2020 after 95 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183544: Efficient Care 3D Planning, Orthosoft Inc (D/B/A Zimmer Cas) (2019) Summary page 4.

## Indications for use
The Zebra HealthJOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative planning of knee orthopedic surgical procedures. Zebra’s HealthJOINT analyzes cases using an artificial intelligence algorithm for the 3D model reconstruction. In addition to the model, the software provides a list of anatomical landmarks with their position on the 3D model. The result is made available via a 3rd parties’ software interface for further display and analysis of the 3D bone model. Clinical judgement and experience are required to properly use the models produced by this software.

Source page: https://510kreport.com/device/K202487
Methodology: https://510kreport.com/methodology