SMR Shoulder
SMR Shoulder - Glenosph. Dia. 42-Ecc.42 Extract. Insert
8manufacturers in China registered for this device type
182catalogue 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) | K100858 |
| Record published | 2020-04-24 |
| Record revised | 2024-09-11 (version 7) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9CC0.95.101 | In distribution | |
| Expansion Extractor | In distribution | |
| Humeral Head (CoCrMo) | Dia.48mm H.16 | In distribution |
| Finned Stem | Dia 21mm | In distribution |
| Impactor Guide | SMALL/STD/LARGE | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.13 Ecc.2 | In distribution |
| Glenoid Drill | SMALL-R | In distribution |
| Humeral Head (CoCrMo) | Dia.48mm H.15 | In distribution |
| Trial Humeral Head | Dia. 42 H. 17mm | In distribution |
| Trial Humeral Head | Dia.50 H.22mm | In distribution |
| Trial Humeral Head | Dia.42mm | In distribution |
| Reverse Resection Jig – LA | In distribution | |
| Resurfacing CTA Head | Dia. 54mm | In distribution |
| Finned Stem | Dia 13mm | In distribution |
| Humeral Head (CoCrMo) | Dia.52mm H.22 | In distribution |
| Trial Humeral Head | Dia. 42 H. 13 Ecc. 7mm | In distribution |
| Trial Stem | Dia. 20 mm | In distribution |
| Trial Stem | Dia. 24 mm | In distribution |
| Trial Humeral Head | Dia. 52 H. 18mm | In distribution |
| Trial Revision Stem | Dia.13mm H180mm | In distribution |
| Extractor | In distribution | |
| Trial Humeral Head | Dia.42 H.18mm | In distribution |
| Trial Humeral Head | Dia.48mm | In distribution |
| Trial Revision Stem | Dia.15mm H180mm | In distribution |
| Trial Modular Spacer | H20mm | In distribution |
| Trial Humeral Head | Dia. 46 H. 14mm | In distribution |
| Trial CTA Head | Dia.46mm | In distribution |
| Revision Stem | dia.13mm, h.180mm | In distribution |
| Trial Revision Stem | Dia.16mm H150mm | In distribution |
| Trial Stem | Dia. 21 mm | In distribution |
| Trial Adaptor | Long Ecc. 4mm | In distribution |
| Trial Adaptor | Ecc.8mm | In distribution |
| Trial Resection Stem | Dia.7mm H80mm | In distribution |
| Trial Revision Stem | Dia.13mm H150mm | In distribution |
| Finned Stem | Dia 24mm | In distribution |
| Centimeter | In distribution | |
| Conical Trial Stem | Dia. 17 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.13 | In distribution |
| Trial Stem | Dia. 18 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.12 Ecc.2 | In distribution |
| 9013.52.148 | In distribution | |
| Finned Stem | Dia 19mm | In distribution |
| Resurfacing CTA Head | Dia. 46mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.17 | In distribution |
| Trial Mini Stem | Dia. 11 mm | In distribution |
| Cemented Revision Stem | dia.13mm, h.180mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 12 Ecc. 2mm | In distribution |
| Trial Revision Stem | Dia.13mm H180mm | In distribution |
| Trial Adaptor | Long Ecc. 2mm | In distribution |
| Resurfacing Head | Dia. 52mm | In distribution |
| Finned Stem | Dia 15mm | In distribution |
| Trial Humeral Head | Dia. 44 H. 13 Ecc. 6mm | In distribution |
| Stop Guide | 45° | In distribution |
| Trial CTA Head | Dia.42mm | In distribution |
| Cannulated Manipulator | In distribution | |
| Cemented Revision Stem | dia.15mm, h.210mm | In distribution |
| Humeral Head (CoCrMo) | Dia.52mm H.17 | In distribution |
| Trial Humeral Head | Dia.40mm | In distribution |
| Trial Humeral Head | Dia.54mm | In distribution |
| Humeral Body | Size M | In distribution |
| CTA Head | Dia 54mm | In distribution |
| Trial Stem | Dia. 15 mm | In distribution |
| Stem | Dia. 13mm L36mm | In distribution |
| Adaptor | In distribution | |
| Trial Resection Stem | Dia.7mm H50mm | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.18 | In distribution |
| Finned Stem | Dia 23mm | In distribution |
| Trial Stem | Dia. 17 mm | In distribution |
| Trial Humeral Head | Dia. 46 H. 19mm | In distribution |
| Prosthesis Introducer | In distribution | |
| Trial Revision Stem | Dia.14mm H210mm | In distribution |
| Reamer | In distribution | |
| Humeral Head (CoCrMo) | Dia.52mm H.23 | In distribution |
| Trial CTA Head | Dia.50mm | In distribution |
| Trial Humeral Body | # MEDIUM | In distribution |
| Trial Revision Stem | Dia.14mm H150mm | In distribution |
| Conical Trial Stem | Dia. 19 mm | In distribution |
| Trial Stem | Dia. 22 mm | In distribution |
| 9CC0.13.009 | In distribution | |
| Glenoid Impactor | In distribution | |
| 9013.74.151 | 42mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.13 Ecc.4 | In distribution |
| 9013.79.583 | Dia. 42-Ecc.42 | In distribution |
| Finned Stem | Dia 20mm | In distribution |
| Trial Stem | Dia. 16 mm | In distribution |
| Reverse Liner Pusher | In distribution | |
| Trial Humeral Head | Dia. 50 H. 16mm | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.12 Ecc.4 | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.13 | In distribution |
| Glenoid Reamer | In distribution | |
| Trial Revision Stem | Dia.14mm H180mm | In distribution |
| Finned Stem | Dia 16mm | In distribution |
| Trial Stem | Dia. 23 mm | In distribution |
| Finned Stem | Dia 17mm | In distribution |
| Adaptor | Dia 36mm | In distribution |
| Revision Stem | dia.16mm, h.180mm | In distribution |
| Glenoid Reamers and Drills Shaft | In distribution | |
| Adaptor Taper | Eccentrical 6mm | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.13 Ecc.7 | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.18 | In distribution |
| Cemented Revision Stem | dia.15mm, h.150mm | In distribution |
| Impactor Guide | In distribution | |
| Humeral Head (CoCrMo) | Dia.44mm H.13 Ecc.4 | In distribution |
| Finned Trial Stem | Dia. 12mm | In distribution |
| Trial Adaptor | Ecc.4mm | In distribution |
| Finned Stem | Dia 14mm | In distribution |
| CTA Head | Dia 46mm | In distribution |
| Trial Humeral Head | Dia.46 H.20mm | In distribution |
| Humeral Head (CoCrMo) | Dia.52mm H.18 | In distribution |
| Finned Stem | Dia 22mm | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.14 | In distribution |
| Trial Humeral Head | Dia.44mm | In distribution |
| Trial Revision Stem | Dia.15mm H150mm | In distribution |
| Anatomic Adaptor Sleeve | In distribution | |
| Glenoid Drill | SMALL-R | In distribution |
| Trial Humeral Head | Dia. 50 H. 21mm | In distribution |
| Trial Humeral Head | Dia. 40 H. 13 Ecc. 2mm | In distribution |
| Trial Adaptor | Long Ecc. 8mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 13mm Neutral | In distribution |
| Trial Revision Stem | Dia.14mm H150mm | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.12 | In distribution |
| Reverse Resection Jig – DPA | In distribution | |
| Reverse Adaptor Sleeve | In distribution | |
| Stem Impactor | In distribution | |
| Humeral Head Press | In distribution | |
| Trial Humeral Head | Dia. 44 H. 13 Ecc. 2mm | In distribution |
| Trial Revision Stem | Dia.16mm H150mm | In distribution |
| Trial Adaptor | Ecc.2mm | In distribution |
| Trial Humeral Head | Dia. 40 H. 13 Ecc. 6mm | In distribution |
| Trial Revision Stem | Dia.16mm H180mm | In distribution |
| Trial Humeral Head | Dia. 54 H. 18mm | In distribution |
| Finned Stem | Dia 18mm | In distribution |
| Revision Stem | dia.15mm, h.180mm | In distribution |
| Trial Humeral Head | Dia. 46 H. 15mm | In distribution |
| Trial Humeral Head | Dia. 54 H. 23mm | In distribution |
| Wrench for Knurled Stems | In distribution | |
| Trial Revision Stem | Dia.16mm H180mm | In distribution |
| Resurfacing Head | Dia. 48mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 12 Ecc. 6mm | In distribution |
| Finned Stem | Dia 11mm | In distribution |
| Trial Modular Augment | H50mm | In distribution |
| Trial Revision Stem | Dia.14mm H180mm | In distribution |
| Trial Modular Augment | H30mm | In distribution |
| Conical Trial Stem | Dia. 21 mm | In distribution |
| Revision Stem | dia.14mm, h.180mm | In distribution |
| Trial Stem | Dia. 19 mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 13 Ecc. 4mm | In distribution |
| Trial Humeral Head | Dia.54 H.24mm | In distribution |
| Trial Revision Stem | Dia.15mm H180mm | In distribution |
| 9013.02.116 | Dia.16 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.13 Ecc.7 | In distribution |
| Humeral Head (CoCrMo) | Dia.48mm H.20 | In distribution |
| Finned Stem | Dia 12mm | In distribution |
| 9013.74.150 | 42mm | In distribution |
| Trial Humeral Head | Dia. 48 H. 16mm | In distribution |
| Conical Trial Stem | Dia. 15 mm | In distribution |
| Trial Stem | Dia. 14 mm | In distribution |
| Trial Revision Stem | Dia.14mm H210mm | In distribution |
| Trial Humeral Head | Dia.52mm | In distribution |
| Trial Revision Stem | Dia.15mm H150mm | In distribution |
| Trial Humeral Head | Dia. 40 H. 12mm Neutral | In distribution |
| Trial Adaptor | Long | In distribution |
| Trial CTA Head | Dia.54mm | In distribution |
| TT Metal Back Impactor | In distribution | |
| Resurfacing Head | Dia. 44mm | In distribution |
| Trial Resection Stem | Dia.10mm H80mm | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.13 Ecc.6 | In distribution |
| Trial Adaptor | In distribution | |
| Trial Revision Stem | Dia.13mm H150mm | In distribution |
| Reverse Adaptor Sleeve | In distribution | |
| Trial Humeral Head | Dia.46mm | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.19 | In distribution |
| Trial Humeral Head | Dia. 40 H. 12 Ecc. 4mm | In distribution |
| Resurfacing Head | Dia. 40mm | In distribution |
| Trial Modular Spacer | H40mm | In distribution |
| Trial Humeral Head | Dia.50mm | In distribution |
| Humeral Head (CoCrMo) | Dia.48mm H.21 | In distribution |
| Trial Resection Stem | Dia.10mm H50mm | In distribution |
| Glenoid Drill | SMALL-R | In distribution |
| Conical Trial Stem | Dia. 23 mm | In distribution |
| Trial Mini Stem | Dia. 13 mm | In distribution |
| Drill Guide | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| 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 |
| SMR System | Limacorporate | 72 |
| 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.