Class Class II
EMPHASYS Acetabular System (K243977)
Description
EMPHASYS Acetabular System by Depuy Ireland UC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243977
Clearance Date2025-01-22
Clearance TypeSpecial
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243977
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. EMPHASYS Acetabular System (K243977) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePu... | Depuy Ireland UC | 2024 |
| K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | 2022 |
| K071784 | DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2007 |
Trace the full predicate network for K243977
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.