# K222195: aprevo® Digital Workflow

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Dec 30, 2022 after 161 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: 4 generations back to K924630 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060950: 3MATIC, Materialise NV (2006) Summary page 4.

## Most influential descendants
- K242599: aprevo® Digital Planning (2024), 0 descendants of its own

## Indications for use
aprevo® Digital Workflow software is intended to view, store, and manipulate 3-D models to visualize surgical plans for spinal alignment. The device inputs a 3-D spine model which is used by trained, medically knowledgeable design personnel in conjunction with inputs from healthcare professionals to produce 3-D models of spinal correction and anatomical measurements. The device outputs are used by healthcare professionals for placement of surgical implants.

Source page: https://510kreport.com/device/K222195
Methodology: https://510kreport.com/methodology