# K163156: SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jan 18, 2017 after 69 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: 6 generations back to K924630 (1993). 10 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132290: Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides, Materialise NV (2014) Summary page 4.

## Most influential descendants
- 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
- K241811: MedCAD® AccuStride™ System (2025), 2 descendants of its own
- K240415: Newclip Patient-matched instrumentation non sterile PSI (2024), 2 descendants of its own
- K243912: Newclip Patient-matched instrumentation non sterile PSI (2025), 1 descendant 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 adult patients; in upper extremity orthopedic surgical procedures and orthopedic surgical procedures around the knee. * For pediatric patients 7 years of age and older; in orthopedic surgical procedures involving the radius and ulna. SurgiCase Guides are intended for single use only.

Source page: https://510kreport.com/device/K163156
Methodology: https://510kreport.com/methodology