# K250921: CORIOGRAPH Pre-Op Planning and Modeling Services

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Jun 25, 2025 after 90 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: 24 generations back to K905070 (1991). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242272: CORIOGRAPH Pre-Op Planning and Modeling Services, Blue Belt Technologies, Inc. (2024) Summary page 5.
- K242813: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Materialise NV (2024) Summary page 5.

## Indications for use
CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans. The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures: • Unicondylar Knee Replacement (UKR) • Total Knee Arthroplasty (TKA) • Primary Total Hip Arthroplasty (THA) • Primary Anatomic Total Shoulder Arthroplasty (aTSA) • Primary Reverse Total Shoulder Arthroplasty (rTSA)

Source page: https://510kreport.com/device/K250921
Methodology: https://510kreport.com/methodology