# K103136: Surgicase CMF, Surgicase Connect, Surgicase Guide

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Mar 18, 2011 after 144 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082358 (2008). 2 ancestors in all.
90 later devices descend from it; 3 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093533: Zimmer Patient Specific Instruments System, Version 2.0, Materialise NV (2010) Summary page 1.
- K082358: Smith & Nephew, Inc. Patient Matched Technology, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K112389: Surgicase Connect, Surgicase Guide (2012), 59 descendants of its own
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K120956: VSP System (2012), 28 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own

## Recalls of this device
- Jun 19, 2023 · Class II · Z-2287-2023: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

## 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 in mandibular and maxillofacial surgical procedures. SurgiCase Guides are intended for single use only.

Source page: https://510kreport.com/device/K103136
Methodology: https://510kreport.com/methodology