Delta Xtend
DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +10mm HA COATED CEMENTLESS
8manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K062250 |
| Record published | 2015-09-24 |
| Record revised | 2024-05-31 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130770042 | In distribution | |
| 130790042 | In distribution | |
| 130738106 | In distribution | |
| 130714110 | In distribution | |
| 130738206 | In distribution | |
| 1407-60-010 | In distribution | |
| 1337-62-042 | In distribution | |
| 130770036 | In distribution | |
| 1337-61-142 | In distribution | |
| 130712200 | In distribution | |
| 130770024 | In distribution | |
| 130790036 | In distribution | |
| 130770030 | In distribution | |
| 1337-62-038 | In distribution | |
| 1307-62-138 | In distribution | |
| 1337-62-138 | In distribution | |
| 1407-60-015 | In distribution | |
| 130710110 | In distribution | |
| 130712110 | In distribution | |
| 130712100 | In distribution | |
| 130770018 | In distribution | |
| 1337-66-042 | In distribution | |
| 130712210 | In distribution | |
| 130714100 | In distribution | |
| 130710210 | In distribution | |
| 1337-68-038 | In distribution | |
| 130790048 | In distribution | |
| 130742206 | In distribution | |
| 1337-61-038 | In distribution | |
| 1337-64-042 | In distribution | |
| 130760042 | In distribution | |
| 1307-61-142 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2017-08-31 | Class II | Nonconforming Material/Component | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. | 23,053 units | 2020-03-12 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2017-08-31 | Class II | Nonconforming Material/Component | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. | Quantities co-mingled under initial product | 2020-03-12 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1, 521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1, 521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.