# Delta Xtend 1407-60-010

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/delta-xtend-140760010>
- Manufacturer: [Depuy (Ireland)](https://devicerts.com/manufacturers/depuy-ireland) (FDA registration: Ireland)
- Name in the registry: DELTA XTEND 1407-60-010
- Device class: Class III (EU MDR); Class II (US FDA)
- FDA product code: HSD, PHX, KWS
- EMDN: P09010301 METAL BACK AND METAGLENE GLENOID BASEPLATES
- GMDN: Reverse shoulder prosthesis base plate (48091)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · MDR 743997 · issued 2026-07-13 · expires 2028-07-17 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 0603295a000908H · UDI-DI 10603295272908 · registered 2026-05-28 · status: Active
- **GUDID** · FDA 510(k) · United States · K192855 · decision 2020-02-24 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 10603295272908 · listed 2020-01-13 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K192448 · decision 2019-10-04 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K120174 · decision 2012-06-11 · decision SESE · status: Active · from GUDID

## EU certificates

- MDR 743997 · Technical documentation · MDR · notified body BSI Group The Netherlands B.V. · issued 2026-07-13 · expires 2028-07-17 · status: supplemented

## Recalls

- Z-0833-2018 · Class II · terminated · initiated 2017-08-31: The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
- Z-0834-2018 · Class II · terminated · initiated 2017-08-31: The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

## Identity

- Trade name: DELTA XTEND [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Reverse shoulder prosthesis base plate [FDA GUDID (AccessGUDID)]
- Device name: DELTA XTEND Metaglene [EUDAMED]
- Model / Ref / Catalog: 1407-60-010 [EUDAMED, FDA GUDID (AccessGUDID)]; DELTA XTEND Metaglene [EUDAMED]; 140760010 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10603295272908 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0603295a000908H [EUDAMED]
- 510(k) Number: K120174 [FDA GUDID (AccessGUDID)]; K192448 [FDA GUDID (AccessGUDID)]; K192855 [FDA GUDID (AccessGUDID)]
- FDA product code: HSD [FDA GUDID (AccessGUDID)]; PHX [FDA GUDID (AccessGUDID)]; KWS [FDA GUDID (AccessGUDID)]
- EMDN code: P09010301 [EUDAMED]
- GMDN term: Reverse shoulder prosthesis base plate (48091) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 888.3690 [FDA GUDID (AccessGUDID)]; 888.3660 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Ireland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Conditional [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Delta Xtend 1407-60-010, Depuy (Ireland). deviCERTS medical device catalogue. https://devicerts.com/devices/delta-xtend-140760010 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/delta-xtend-140760010.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/delta-xtend-140760010
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.