Class Class II
InSet Total Shoulder System (K241817)
Description
InSet Total Shoulder System by Shoulder Innovations, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241817
Clearance Date2025-02-11
Clearance TypeTraditional
Product CodeKWT
Regulation Number888.3650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241817
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. InSet Total Shoulder System (K241817) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212737 | INHANCE Reverse Shoulder System | Depuy Ireland UC | 2022 |
| K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019 |
| K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | Biomet Manufacturing Corp | 2006 |
Trace the full predicate network for K241817
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.