Class Class II
Zimmer Biomet Ceramic Heads (22.2mm diameter) (K250834)
Description
Zimmer Biomet Ceramic Heads (22.2mm diameter) by Zimmer Biomet, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250834
Clearance Date2025-04-18
Clearance TypeSpecial
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250834
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. Zimmer Biomet Ceramic Heads (22.2mm diameter) (K250834) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 |
| K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | 2019 |
Trace the full predicate network for K250834
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.