Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (K214001)
Description
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System by Biomet Manufacturing Corp, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K214001
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. Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (K214001) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp | 2021 |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020 |
| K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020 |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive S... | Biomet Manufacturing Corp | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250848 | Identity Shoulder System | Zimmer, Inc. | 2025 |
Trace the full predicate network for K214001
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.