Delta Xtend
Delta Xtend REVERSE SHOULDER SYSTEM CENTRAL SCREW METAGLENE COLLET Implant: Titanium / Handle: Polycarbonate
9manufacturers in China registered for this device type
61catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K192855 |
| Record published | 2020-04-24 |
| Record revised | 2025-03-06 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1307-20-113 | In distribution | |
| 130710200 | In distribution | |
| 1307-20-221 | In distribution | |
| 1307-20-111 | In distribution | |
| 1337-66-142 | In distribution | |
| 1307-61-042 | In distribution | |
| 130710100 | In distribution | |
| 1307-20-222 | In distribution | |
| 1307-20-223 | In distribution | |
| 130748026 | In distribution | |
| 1307-66-142 | In distribution | |
| 1309-60-111 | In distribution | |
| 1307-40-103 | In distribution | |
| 130760142 | In distribution | |
| 1337-68-142 | In distribution | |
| 140760025 | In distribution | |
| 2307-70-014 | In distribution | |
| 1309-70-400 | In distribution | |
| 130790030 | In distribution | |
| 130738203 | In distribution | |
| 1309-60-315 | In distribution | |
| 1309-60-000 | In distribution | |
| 1307-62-038 | In distribution | |
| 130742106 | In distribution | |
| 130708100 | In distribution | |
| 1307-68-038 | In distribution | |
| 1309-60-325 | In distribution | |
| 2307-70-010 | In distribution | |
| 1307-68-138 | In distribution | |
| 1307-66-038 | In distribution | |
| 130760038 | In distribution | |
| 1337-61-138 | In distribution | |
| 1337-64-038 | In distribution | |
| 130742203 | In distribution | |
| 130738209 | In distribution | |
| 140760020 | In distribution | |
| 1309-60-320 | In distribution | |
| 1307-68-142 | In distribution | |
| 1307-30-202 | In distribution | |
| 1309-60-350 | In distribution | |
| 1307-61-038 | In distribution | |
| 130730009 | In distribution | |
| 1307-61-138 | In distribution | |
| 1309-60-330 | In distribution | |
| 130790024 | In distribution | |
| 130752021 | In distribution | |
| 1337-64-142 | In distribution | |
| 1337-64-138 | In distribution | |
| 130708110 | In distribution | |
| 1307-64-038 | In distribution | |
| 130742209 | In distribution | |
| 130714210 | In distribution | |
| 130752026 | In distribution | |
| 130748021 | In distribution | |
| 1307-40-101 | In distribution | |
| 130714200 | In distribution | |
| 130760138 | In distribution | |
| 1337-66-138 | In distribution | |
| 1307-66-042 | In distribution | |
| 2307-70-012 | In distribution | |
| 1309-60-340 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133834 | 2014-04-03 |
Recalls Naming This Product
18 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 | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 28 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 432 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 3 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 781 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 3 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 870 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 451 units | 2024-05-17 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-12-07 | Class II | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | 140 units | 2024-05-17 |
| 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.