Class Class II
restor3d Reverse Total Shoulder Arthroplasty System (K243643)
Description
restor3d Reverse Total Shoulder Arthroplasty System by Restor3d, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243643
Clearance Date2025-05-19
Clearance TypeTraditional
Product CodePHX
Regulation Number888.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243643
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. restor3d Reverse Total Shoulder Arthroplasty System (K243643) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | 2024 |
| K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020 |
| K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020 |
Trace the full predicate network for K243643
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.