SMR System
SMR System - Humeral Head Dia. 40 mm H. 12 mm Eccentrical 2mm
8manufacturers in China registered for this device type
72catalogue 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 | Limacorporate, Italy |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| 510(k) | K101263 |
| Record published | 2024-02-22 |
| Record revised | 2025-03-06 (version 2) |
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 |
|---|---|---|
| 1304.15.170 | Dia. 17 mm L. 80 mm | In distribution |
| 1325.09.401 | Dia. 40 mm H. 18 mm | In distribution |
| 1322.09.521 | Dia. 52 mm H. 17 mm | In distribution |
| 1322.09.501 | Dia. 50 mm H. 16 mm | In distribution |
| 1304.15.140 | Dia. 14 mm L. 80 mm | In distribution |
| 1304.15.160 | Dia. 16 mm L. 80 mm | In distribution |
| 1304.15.180 | Dia. 18 mm L. 80 mm | In distribution |
| 1304.15.230 | Dia. 23 mm L. 80mm | In distribution |
| 1322.09.402 | Dia. 40 mm H. 12 mm Eccentrical 2mm | In distribution |
| 1322.09.421 | Dia. 42 mm H. 12 mm Neutral | In distribution |
| 1321.09.461 | Dia. 46 mm H. 15 mm | In distribution |
| 1324.09.541 | Dia. 54 mm H. 23 mm | In distribution |
| 1304.15.240 | Dia. 24 mm L. 80 mm | In distribution |
| 1321.09.427 | Dia. 42 mm H. 13 mm Eccentrical 7mm | In distribution |
| 1304.15.130 | Dia. 13 mm L. 60 mm | In distribution |
| 1324.09.461 | Dia. 46 mm H. 19 mm | In distribution |
| 1322.09.422 | Dia. 42 mm H. 12 mm Eccentrical 2mm | In distribution |
| 1304.15.210 | Dia. 21 mm L. 80 mm | In distribution |
| 1322.09.481 | Dia. 48 mm H. 15 mm | In distribution |
| 1321.09.424 | Dia. 42 mm H. 13 mm Eccentrical 4mm | In distribution |
| 1321.09.426 | Dia. 42 mm H. 13 mm Eccentrical 6mm | In distribution |
| 1321.09.406 | Dia. 40 mm H. 13 mm Eccentrical 6mm | In distribution |
| 1322.09.447 | Dia. 44 mm H. 13 mm Eccentrical 7mm | In distribution |
| 1321.09.404 | Dia. 40 mm H. 13 mm Eccentrical 4mm | In distribution |
| 1324.09.501 | Dia. 50 mm H. 21 mm | In distribution |
| 1322.09.424 | Dia. 42 mm H. 12 mm Eccentrical 4mm | In distribution |
| 1317.15.020 | Dia. 13 mm L. 36 mm | In distribution |
| 1304.15.190 | Dia. 19 mm L. 80 mm | In distribution |
| 1378.50.005 | Small-R | In distribution |
| 1322.09.404 | Dia. 40 mm H. 12 mm Eccentrical 4mm | In distribution |
| 1325.09.541 | Dia. 54 mm H. 24 mm | In distribution |
| 1322.09.446 | Dia. 44 mm H. 13 mm Eccentrical 6mm | In distribution |
| 1352.15.200 | Dia. 36 mm | In distribution |
| 1304.15.220 | Dia. 22 mm L. 80 mm | In distribution |
| 1325.09.481 | Dia. 48 mm H. 21 mm | In distribution |
| 1330.15.276 | Eccentrical 6mm | In distribution |
| 1350.15.110 | Medium | In distribution |
| 1322.09.442 | Dia. 44 mm H. 13 mm Eccentrical 2mm | In distribution |
| 1324.09.401 | Dia. 40 mm H. 17 mm | In distribution |
| 1322.09.444 | Dia. 44 mm H. 13 mm Eccentrical 4mm | In distribution |
| 1331.15.276 | Eccentrical 6mm Long | In distribution |
| 1378.50.020 | Small | In distribution |
| 1321.09.521 | Dia. 52 mm H. 18 mm | In distribution |
| 1321.09.402 | Dia. 40 mm H. 13 mm Eccentrical 2mm | In distribution |
| 1321.09.441 | Dia. 44 mm H. 14 mm | In distribution |
| 1304.15.110 | Dia. 11 mm L. 60 mm | In distribution |
| 1321.09.541 | Dia. 54 mm H. 19 mm | In distribution |
| 1321.09.407 | Dia. 40 mm H. 13 mm Eccentrical 7mm | In distribution |
| 1324.09.521 | Dia. 52 mm H. 22 mm | In distribution |
| 1317.15.010 | Dia. 11 mm L.32 mm | In distribution |
| 1321.09.421 | Dia. 42 mm H. 13 mm Neutral | In distribution |
| 1304.15.150 | Dia. 15 mm L. 80 mm | In distribution |
| 1324.09.441 | Dia. 44 mm H. 18 mm | In distribution |
| 1321.09.401 | Dia. 40 mm H. 13 mm Neutral | In distribution |
| 1325.09.521 | Dia. 52 mm H. 23 mm | In distribution |
| 1325.09.421 | Dia. 42 mm H. 18 mm | In distribution |
| 1324.09.481 | Dia. 46 mm H. 19 mm | In distribution |
| 1321.09.481 | Dia. 48 mm H. 16 mm | In distribution |
| 1325.09.501 | Dia. 50 mm H. 22 mm | In distribution |
| 1322.09.426 | Dia. 42 mm H. 12 mm Eccentrical 6mm | In distribution |
| 1322.09.541 | Dia. 54 mm H. 18 mm | In distribution |
| 1325.09.441 | Dia. 44 mm H. 19 mm | In distribution |
| 1378.50.010 | Standard | In distribution |
| 1324.09.421 | Dia. 42 mm H. 17 mm | In distribution |
| 1304.15.120 | Dia. 12 mm L. 60 mm | In distribution |
| 1304.15.200 | Dia. 20 mm L. 80 mm | In distribution |
| 1325.09.461 | Dia. 46 mm H. 20 mm | In distribution |
| 1321.09.422 | Dia. 42 mm H. 13 mm Eccentrical 2mm | In distribution |
| 1322.09.461 | Dia. 46 mm H. 14 mm | In distribution |
| 1322.09.441 | Dia. 44 mm H. 13 mm Neutral | In distribution |
| 1321.09.501 | Dia. 50 mm H. 17 mm | In distribution |
| 1322.09.401 | Dia. 40 mm H. 12 mm Neutral | 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 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Limacorporate S.p.A. | 510(k) number | 2015-08-14 | Class II | Nonconforming Material/Component | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | 110 units | 2016-02-26 |
| Limacorporate S.p.A. | 510(k) number | 2015-08-14 | Class II | Nonconforming Material/Component | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | 93 units | 2016-02-26 |
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.