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DELTA XTEND Reverse Shoulder System

by DePuy Ireland UC

510(k) K203694

Active European Union and United States

CE MDR 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) K203694↗

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 NumberK203694 Date22 Jul 2021ClearedStatusActive
European UnionCE/MDR 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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
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 Delta XTEND Reverse Shoulder System is a reverse shoulder arthroplasty device designed for the replacement of the shoulder joint in patients with conditions such as rotator cuff arthropathy, severe osteoarthritis, or post-traumatic arthritis. It features a reverse ball-and-socket design to restore function and stability by transferring the deltoid muscle’s force to the humeral component, enabling improved mobility for the patient.

This system is supplied as a sterile, single-use orthopedic implant intended for surgical use in certified orthopedic operating rooms. It is available in various component sizes to accommodate different anatomical requirements and is regulated under FDA 510(k) clearance and MDR compliance. Proper handling, storage, and adherence to manufacturer guidelines are essential to ensure sterility and functionality prior to implantation.

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