# K112389: Surgicase Connect, Surgicase Guide

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jul 20, 2012 after 337 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924630 (1993). 8 ancestors in all.
59 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073449: Surgicase, Materialise NV (2008) Summary page 1.
- K103136: Surgicase CMF, Surgicase Connect, Surgicase Guide, Materialise NV (2011) Summary page 1.

## Most influential descendants
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own

## Indications for use
The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies for upper extremity orthopedic surgical procedures. The system is to be used for adult patients. SurgiCase Guides are intended for single use only.

Source page: https://510kreport.com/device/K112389
Methodology: https://510kreport.com/methodology