# K124051: The Vault System

- Pathway: 510(k) (Traditional)
- Applicant: Somersault Orthopedics, Inc.
- Decided: May 17, 2013 after 137 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: 8 generations back to K896095 (1990). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073468: Mimics, Materialise NV (2008) Summary page 1.
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 1.

## Most influential descendants
- K202521: PtoleMedic System (2021), 0 descendants of its own

## Indications for use
The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Source page: https://510kreport.com/device/K124051
Methodology: https://510kreport.com/methodology