Skip to content

Pantheon Proximal Femur Reconstruction System

by Adler Ortho S.p.A

510(k) K241059

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241059↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241059 Date13 Jan 2025ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Pantheon Proximal Femur Reconstruction (PFR) System
510(k) Number
FDA Product Code
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pantheon Proximal Femur Reconstruction System is a modular orthopedic implant designed for proximal femoral reconstruction. It is classified as a large resection prosthesis, intended for addressing significant bone loss due to oncology, trauma, infection, or failed joint replacements. The system includes proximal implant bodies with two resection levels (50mm and 70mm) and varying offsets, along with trochanteric salvage plates for soft tissue fixation.

This system is supplied as a sterile, single-use modular orthopedic implant set, intended for surgical use in orthopedic procedures. It is regulated under the FDA 510(k) pathway with a Traditional clearance (K241059) and complies with the Medical Device Directive (MDD). The modular components allow for customization to match specific patient anatomy and clinical needs, ensuring precise reconstruction and stability.

Other devices from Adler Ortho S.p.A

See all devices from Adler Ortho S.p.A →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of bone loss conditions is the Pantheon Proximal Femur Reconstruction System specifically designed to address in the proximal femur?

    The Pantheon Proximal Femur Reconstruction System is designed for significant bone loss in the proximal femur caused by oncology (cancer), trauma, infection, or failed joint replacements. Its modular components allow for customization to match specific anatomical needs, ensuring stability during reconstruction.

  • How is the Pantheon Proximal Femur Reconstruction System supplied, and is it reusable?

    The system is supplied as a sterile, single-use modular orthopedic implant set, meaning each component is intended for one surgical procedure only. This ensures sterility and reduces the risk of cross-contamination.

  • What variations in proximal implant bodies and trochanteric components are included in the Pantheon system?

    The system includes proximal implant bodies with two resection levels (50mm and 70mm) and multiple offsets to accommodate different patient anatomies. Additionally, trochanteric salvage plates are provided for soft tissue fixation, allowing for tailored reconstruction.

  • How is the regulatory pathway for the Pantheon Proximal Femur Reconstruction System determined?

    The system is regulated under the FDA’s 510(k) pathway with a Traditional clearance (K241059), meaning it was evaluated for substantial equivalence to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) in Europe.