Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K230315)
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 K230315
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 (K230315) cites 9 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide an... | Materialise NV | 2022 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 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 |
| K153602 | Materialise Glenoid Positioning System | Materialise NV | 2016 |
| K131559 | MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYST... | Materialise NV | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242813 | Materialise Shoulder System™, Materialise Shoulder Guide an... | Materialise NV | 2024 |
| K241143 | Materialise Shoulder System™, Materialise Shoulder Guide an... | Materialise NV | 2024 |
Trace the full predicate network for K230315
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.