# K132290: Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Apr 10, 2014 after 261 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: 5 generations back to K924630 (1993). 9 ancestors in all.
18 later devices descend from it; 3 cite 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)
- K112389: Surgicase Connect, Surgicase Guide, Materialise NV (2012) Summary page 1.

## Most influential descendants
- K163156: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (2017), 8 descendants of its own
- K193614: FINE Osteotomy around the knee (2020), 4 descendants of its own
- K221615: Newclip Patient-matched instrumentation non sterile PSI (2023), 3 descendants of its own
- K220717: RedPoint Medical's Better Bunion System (2022), 3 descendants of its own
- K211646: FINE Osteotomy (2021), 3 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 and osteotomies around the knee. The system is to be used for adult patients. SurgiCase Guides are intended for single use only.

Source page: https://510kreport.com/device/K132290
Methodology: https://510kreport.com/methodology