Class Class II
Catalyst R1 Reverse Shoulder System (K223655)
Description
Catalyst R1 Reverse Shoulder System by Catalyst Orthoscience, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223655
Clearance Date2023-05-09
Clearance TypeTraditional
Product CodePHX
Regulation Number888.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223655
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. Catalyst R1 Reverse Shoulder System (K223655) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022 |
| K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 |
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016 |
| K092873 | REVERSE SHOULDER PROSTHESIS | Djo Surgical | 2009 |
Trace the full predicate network for K223655
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.