Class Class II
EMPHASYS Acetabular Shell with RapiTite HA (K242084)
Description
EMPHASYS Acetabular Shell with RapiTite HA by Depuy Ireland UC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242084
Clearance Date2024-10-07
Clearance TypeTraditional
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242084
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 Shell with RapiTite HA (K242084) cites 6 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 |
| K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRIT... | Howmedica Osteonics Corp. | 2011 |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009 |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009 |
| K031495 | PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS | DePuy Orthopaedics, Inc. | 2003 |
Trace the full predicate network for K242084
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.