Class Class II
Identity Shoulder System (K250848)
Description
Identity Shoulder System by Zimmer, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250848
Clearance Date2025-07-02
Clearance TypeTraditional
Product CodeMBF
Regulation Number888.3670
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250848
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. Identity Shoulder System (K250848) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shou... | Biomet Manufacturing Corp | 2023 |
| K213856 | Identity Shoulder System | Zimmer, Inc. | 2022 |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020 |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019 |
Trace the full predicate network for K250848
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.