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Duocentric Reversed

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103251

by Aston Medical

Identifiers

510(k) Number
K103251 FDA 510(k)
FDA Product Code
PHX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3660 FDA 510(k)
Regulation Number
888.3660 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Duocentric Reversed is a revision humeral head prosthesis designed for reverse shoulder arthroplasty (RSA). This cementless device is engineered to address mechanical conflicts, such as scapular notching, by optimizing the center of rotation to improve humeral excursion and reduce complications associated with adduction.

Supplied as a single-use implant, the Duocentric Reversed is intended for surgical use in orthopedic settings. It holds FDA 510(k) clearance (K103251) under the Traditional pathway, with a product code of PHX. Sterility and sizing details are not specified in the provided data, but compliance with orthopedic implant regulations applies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Revision humeral head prosthesis - DUOCENTRIC® - Aston Medical - cementless, Aston Medical Duocentric® Reversed Prosthesis: Proposition of New ..., PDF Aston Medical Duocentric® Reversed 31 Prosthesis ... - Springer

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aston Medical

Sources (1)

  • FDA 510(k) K103251 24 fields · synced Sep 19, 2026