Anatomic Shoulder Prosthesis
Humeral Anatomical Metaphysis – Cementless, Size 11, 142°
9manufacturers in China registered for this device type
90catalogue numbers in this listing
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 | Medacta International SA, Switzerland |
|---|---|
| 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, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K170910 |
| Record published | 2017-08-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.01.0050 | In distribution | |
| 04.01.0064 | In distribution | |
| 04.01.0096 | In distribution | |
| 04.01.0041 | In distribution | |
| 04.01.0053 | In distribution | |
| 04.01.0011 | In distribution | |
| 04.01.0062 | In distribution | |
| 04.01.0060 | In distribution | |
| 04.01.0009 | In distribution | |
| 04.01.0084 | In distribution | |
| 04.01.0128 | In distribution | |
| 04.01.0044 | In distribution | |
| 04.01.0001 | In distribution | |
| 04.01.0052 | In distribution | |
| 04.01.0073 | In distribution | |
| 04.01.0025 | In distribution | |
| 04.01.0039 | In distribution | |
| 04.01.0082 | In distribution | |
| 04.01.0130 | In distribution | |
| 04.01.0005 | In distribution | |
| 04.01.0047 | In distribution | |
| 04.01.0007 | In distribution | |
| 04.01.0069 | In distribution | |
| 04.01.0038 | In distribution | |
| 04.01.0045 | In distribution | |
| 04.01.0048 | In distribution | |
| 04.01.0086 | In distribution | |
| 04.01.0010 | In distribution | |
| 04.01.0035 | In distribution | |
| 04.01.0043 | In distribution | |
| 04.01.0098 | In distribution | |
| 04.01.0042 | In distribution | |
| 04.01.0054 | In distribution | |
| 04.01.0077 | In distribution | |
| 04.01.0088 | In distribution | |
| 04.01.0071 | In distribution | |
| 04.01.0023 | In distribution | |
| 04.01.0030 | In distribution | |
| 04.01.0026 | In distribution | |
| 04.01.0003 | In distribution | |
| 04.01.0129 | In distribution | |
| 04.01.0134 | In distribution | |
| 04.01.0055 | In distribution | |
| 04.01.0033 | In distribution | |
| 04.01.0135 | In distribution | |
| 04.01.0131 | In distribution | |
| 04.01.0097 | In distribution | |
| 04.01.0056 | In distribution | |
| 04.01.0094 | In distribution | |
| 04.01.0018 | In distribution | |
| 04.01.0022 | In distribution | |
| 04.01.0051 | In distribution | |
| 04.01.0027 | In distribution | |
| 04.01.0067 | In distribution | |
| 04.01.0089 | In distribution | |
| 04.01.0014 | In distribution | |
| 04.01.0175 | In distribution | |
| 04.01.0075 | In distribution | |
| 04.01.0002 | In distribution | |
| 04.01.0029 | In distribution | |
| 04.01.0090 | In distribution | |
| 04.01.0008 | In distribution | |
| 04.01.0006 | In distribution | |
| 04.01.0080 | In distribution | |
| 04.01.0046 | In distribution | |
| 04.01.0137 | In distribution | |
| 04.01.0036 | In distribution | |
| 04.01.0034 | In distribution | |
| 04.01.0016 | In distribution | |
| 04.01.0012 | In distribution | |
| 04.01.0024 | In distribution | |
| 04.01.0049 | In distribution | |
| 04.01.0091 | In distribution | |
| 04.01.0020 | In distribution | |
| 04.01.0133 | In distribution | |
| 04.01.0004 | In distribution | |
| 04.01.0028 | In distribution | |
| 04.01.0136 | In distribution | |
| 04.01.0037 | In distribution | |
| 04.01.0092 | In distribution | |
| 04.01.0095 | In distribution | |
| 04.01.0066 | In distribution | |
| 04.01.0031 | In distribution | |
| 04.01.0132 | In distribution | |
| 04.01.0058 | In distribution | |
| 04.01.0093 | In distribution | |
| 04.01.0040 | In distribution | |
| 04.01.0032 | In distribution | |
| 04.01.0078 | In distribution | |
| 04.01.0099 | 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 |
| Cofield | Smith & Nephew, Inc. | 76 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medacta Usa Inc | 510(k) number | 2019-11-04 | Class II | Device Design | Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis. | 207 units | 2021-05-21 |
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.