# K241059: Pantheon Proximal Femur Reconstruction (PFR) System

- Pathway: 510(k) (Traditional)
- Applicant: Adler Ortho S.P.A
- Decided: Jan 13, 2025 after 270 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931641 (1994). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 6.
- K040749: Modular Replacement System Cemented Stems, Howmedica Osteonics Corp. (2004) Summary page 6.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 6.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 6.
- K112898: Delta TT Cups, Delta TT Liners, Bone Screws, Lima Corporate S.P.A. (2012) Summary page 6.
- K072963: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2008) Summary page 6.
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen, Zimmer, Inc. (2011) Summary page 6.

## Indications for use
The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor. The FIXA Ti-Por cup is intended for cementless use.

Source page: https://510kreport.com/device/K241059
Methodology: https://510kreport.com/methodology