# K213922: FX SPS

- Pathway: 510(k) (Traditional)
- Applicant: Pixee Medical
- Decided: Jul 22, 2022 after 219 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: 11 generations back to K896095 (1990). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201928: e-Ortho Shoulder Software, FH Industrie (2020) Summary page 4.

## Most influential descendants
- K252665: brAIn™ Shoulder Positioning (2025), 0 descendants of its own
- K243292: brAIn™ Shoulder Positioning (2025), 0 descendants of its own

## Indications for use
FX SPS is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Source page: https://510kreport.com/device/K213922
Methodology: https://510kreport.com/methodology