# K202521: PtoleMedic System

- Pathway: 510(k) (Traditional)
- Applicant: Lento Medical Innovation, Inc.
- Decided: May 4, 2021 after 245 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: 9 generations back to K896095 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124051: The Vault System, Somersault Orthopedics, Inc. (2013) Summary page 4.

## Indications for use
The PtoleMedic System is an on-line orthopedic surgical planning software system. MRI images supply data sufficient to allow accurate modeling of anatomy for on-line surgical planning before knee joint replacement surgery. The surgeon preoperatively plans, reviews, adjusts and orients implant images to select implant size and create an idealized surgical plan for the first bony cuts only.

Source page: https://510kreport.com/device/K202521
Methodology: https://510kreport.com/methodology