# K242599: aprevo® Digital Planning

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Dec 20, 2024 after 112 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: 5 generations back to K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222195: aprevo® Digital Workflow, Carlsmed, Inc. (2022) Summary page 5.

## Indications for use
The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.

Source page: https://510kreport.com/device/K242599
Methodology: https://510kreport.com/methodology