SMR System
SMR System - Revision Stem Cemented Dia. 15 mm H. 210 mm
9manufacturers in China registered for this device type
53catalogue 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 | Limacorporate, Italy |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K110847 |
| Record published | 2024-02-22 |
| Record revised | 2025-03-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-07-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1323.09.420 | Dia. 42 mm | In distribution |
| 1309.15.158 | Dia. 15 mm H. 210 mm | In distribution |
| 1375.14.662 | Small/Standard Medium | In distribution |
| 1375.14.652 | Small-R Medium | In distribution |
| 1376.09.030 | Eccentrical Dia. 36 mm | In distribution |
| 1327.10.480 | Dia. 48 mm | In distribution |
| 1377.50.005 | Small-R | In distribution |
| 1375.21.005 | Small-R | In distribution |
| 1375.14.653 | Small-R Long | In distribution |
| 1377.50.010 | Standard | In distribution |
| 1375.21.020 | Small | In distribution |
| 1327.10.460 | Dia. 46 mm | In distribution |
| 1308.15.154 | Dia. 15 mm H. 150 mm | In distribution |
| 1360.50.810 | Standard | In distribution |
| 1375.14.663 | Small/Standard Long | In distribution |
| 1327.10.400 | Dia. 40 mm | In distribution |
| 1352.15.010 | In distribution | |
| 1327.10.500 | Dia. 50 mm | In distribution |
| 1327.10.440 | Dia. 44 mm | In distribution |
| 1308.15.146 | Dia. 14 mm H. 180 mm | In distribution |
| 1360.50.820 | +6mm | In distribution |
| 1360.50.815 | +3mm | In distribution |
| 1376.09.025 | Eccentrical Dia. 36 mm Small-R | In distribution |
| 1323.09.460 | Dia. 46 mm | In distribution |
| 1327.10.420 | Dia. 42 mm | In distribution |
| 1308.15.164 | Dia. 16 mm H. 150 mm | In distribution |
| 1323.09.500 | Dia. 50 mm | In distribution |
| 1309.15.154 | Dia. 15 mm H. 150 mm | In distribution |
| 1309.15.156 | Dia. 15 mm H. 180 mm | In distribution |
| 1376.09.031 | Eccentrical Dia. 36 mm | In distribution |
| 1323.09.540 | Dia. 54 mm | In distribution |
| 1375.14.651 | Small-R Short | In distribution |
| 1308.15.166 | Dia. 16 mm H. 180 mm | In distribution |
| 1375.14.654 | Small-R X-Long | In distribution |
| 1377.50.030 | Large | In distribution |
| 1327.10.520 | Dia. 52 mm | In distribution |
| 1309.15.138 | Dia. 13 mm H. 210 mm | In distribution |
| 1374.09.111 | Dia. 36 mm | In distribution |
| 1375.14.664 | Small/Standard X-Long | In distribution |
| 9CC0.95.097 | In distribution | |
| 1327.10.540 | Dia. 54 mm | In distribution |
| 1328.10.540 | Dia. 54 mm | In distribution |
| 1375.14.661 | Small/Standard Short | In distribution |
| 9013.75.390 | In distribution | |
| 1377.50.020 | Small | In distribution |
| 9CCU.10.014 | 30° +5mm | In distribution |
| 1375.21.010 | Standard | In distribution |
| 1375.21.030 | Large | In distribution |
| 1328.10.500 | Dia. 50 mm | In distribution |
| 1328.10.460 | Dia. 46 mm | In distribution |
| 1328.10.420 | Dia. 42 mm | In distribution |
| 1352.15.005 | Short | In distribution |
| 9CC0.95.097 | Withdrawn |
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 |
|---|---|
| K213785 | 2022-05-13 |
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 | 2023-02-21 | Class II | Process control | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation | 1 | |
| Limacorporate S.p.A. | 510(k) number | 2016-04-08 | Class II | Component design/selection | Complaints of intra-operative breakage of the glenosphere impactors/extractors. | 314 units | 2016-12-05 |
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.