Class Class II
Pantheon Proximal Femur Reconstruction (PFR) System (K241059)
Description
Pantheon Proximal Femur Reconstruction (PFR) System by Adler Ortho S.P.A, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241059
Clearance Date2025-01-13
Clearance TypeTraditional
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241059
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. Pantheon Proximal Femur Reconstruction (PFR) System (K241059) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K112898 | DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS | Lima Corporate S.P.A. | 2012 |
| K072963 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2008 |
| K071535 | BIOLOX DELTA CERAMIC FEMORAL HEAD | Zimmer, Inc. | 2007 |
| K040749 | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS | Howmedica Osteonics Corp. | 2004 |
| K023087 | GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) | Howmedica Osteonics Corp. | 2002 |
Trace the full predicate network for K241059
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.