Global Unite
Global Unite Porocoat Anatomic Proximal Body 135 Degree Size 6/8 Porocoat
9manufacturers in China registered for this device type
31catalogue 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) | K133834 |
| Record published | 2015-09-24 |
| Record revised | 2024-09-11 (version 7) |
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 |
|---|---|---|
| 1100-50-000 | In distribution | |
| 1100-40-510 | In distribution | |
| 1100-52-520 | In distribution | |
| 1100-20-020 | In distribution | |
| 1100-50-120 | In distribution | |
| 1100-30-000 | In distribution | |
| 1100-60-110 | In distribution | |
| 1100-48-600 | In distribution | |
| 1100-40-530 | In distribution | |
| 1100-52-620 | In distribution | |
| 1100-50-110 | In distribution | |
| 1100-40-600 | In distribution | |
| 1100-08-100 | In distribution | |
| 1100-30-020 | In distribution | |
| 1100-60-020 | In distribution | |
| 1100-60-000 | In distribution | |
| 1100-40-100 | In distribution | |
| 1100-30-120 | In distribution | |
| 1100-44-530 | In distribution | |
| 1100-48-610 | In distribution | |
| 2100-70-410 | In distribution | |
| 2100-70-700 | In distribution | |
| 1100-60-100 | In distribution | |
| 1100-20-000 | In distribution | |
| 1100-20-500 | In distribution | |
| 1100-60-120 | In distribution | |
| 1100-56-510 | In distribution | |
| 2100-70-415 | In distribution | |
| 1100-12-600 | In distribution | |
| 1100-40-000 | In distribution | |
| 1100-56-610 | 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
9 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 | 2017-11-28 | Class II | Employee error | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. | 85 | 2020-03-27 |
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.