SMR System
SMR System - Adaptor Taper Eccentrical 4mm Long
6manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Limacorporate, Italy |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 510(k) | K100858 |
| Record published | 2025-06-10 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9013.22.202 | In distribution | |
| 1330.15.272 | Eccentrical 2mm | In distribution |
| 1375.15.610 | Standard | In distribution |
| 1322.09.500 | Dia. 50 mm | In distribution |
| 1331.15.274 | Eccentrical 4mm Long | In distribution |
| 1375.15.605 | Small-R | In distribution |
| 1330.15.270 | Neutral | In distribution |
| 1306.15.180 | Dia. 18 mm L. 80 mm | In distribution |
| 1322.09.480 | Dia. 48 mm | In distribution |
| 1331.15.278 | Eccentrical 8mm Long | In distribution |
| 1322.09.460 | Dia. 46 mm | In distribution |
| 1322.09.520 | Dia. 52 mm | In distribution |
| 1306.15.200 | Dia. 20 mm L. 80 mm | In distribution |
| 1322.09.400 | Dia 40mm | In distribution |
| 1331.15.272 | Eccentrical 2mm Long | In distribution |
| 1322.09.540 | Dia. 54 mm | In distribution |
| 1306.15.160 | Dia. 16 mm L. 80 mm | In distribution |
| 1375.15.620 | Small | In distribution |
| 1306.15.120 | Dia. 12 mm L. 80 mm | In distribution |
| 1350.15.020 | Long | In distribution |
| 1350.15.010 | Medium | In distribution |
| 1322.09.420 | Dia. 42 mm | In distribution |
| 1330.15.274 | Eccentrical 4mm | In distribution |
| 1306.15.140 | Dia. 14 mm L. 80 mm | In distribution |
| 9075.10.135 | In distribution | |
| 1322.09.440 | Dia. 44 mm | In distribution |
| 9013.22.201 | In distribution | |
| 1331.15.270 | Long Neutral | In distribution |
| 9013.22.200 | In distribution | |
| 1350.15.030 | Short | In distribution |
| 1330.15.278 | Eccentrical 8mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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.