# K111558: Surgicase Guide

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Mar 27, 2012 after 298 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K082358 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103136: Surgicase CMF, Surgicase Connect, Surgicase Guide, Materialise NV (2011) Summary page 1.

## Indications for use
SurgiCase Guides are intended to be used as surgical tools to transfer a pre-operative plan to the surgery. The devices are intended to guide the marking of bone and/or guide surgical instruments during craniofacial osteotomies. SurgiCase Guides are intended for single use only.

Source page: https://510kreport.com/device/K111558
Methodology: https://510kreport.com/methodology