Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K242813)
Description
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner by Materialise N.V, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242813
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K242813) cites 12 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2024 |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide an... | Materialise NV | 2024 |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANC... | Depuy Ireland UC | 2023 |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide an... | Materialise NV | 2023 |
| K231112 | Materialise Shoulder System, Materialise Shoulder Guide an... | Materialise NV | 2023 |
| K230315 | Materialise Shoulder System Materialise Shoulder Guide and... | Materialise NV | 2023 |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide an... | Materialise NV | 2022 |
| K212569 | Materialise Shoulder System, Materialise Shoulder Guide an... | Materialise NV | 2022 |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCas... | Materialise NV | 2020 |
| K190286 | Materialise Glenoid Positioning System | Materialise NV | 2019 |
| K172054 | Materialise Glenoid Positioning System | Materialise NV | 2017 |
| K170893 | Materialise Glenoid Positioning System | Materialise NV | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 |
Trace the full predicate network for K242813
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.