SMR Shoulder – Hybrid Glenoid
Glenosphere Dia. 40 mm - Ecc. 40mm Extraction Insert
6manufacturers in China registered for this device type
28catalogue 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) | K163397 |
| Record published | 2017-07-05 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Glenoid Drill | S | In distribution |
| Trial Glenoid | STD – Peg L | In distribution |
| Baseplate Extractor | In distribution | |
| Trial Glenoid | SMALL LOW +2mm | In distribution |
| Trial Glenoid | LARGE LOW +2mm | In distribution |
| Glenosphere Reamer | Dia. 36 mm | In distribution |
| Glenoid Drill Guide | SMALL | In distribution |
| Removal Guide | SMALL | In distribution |
| Glenoid Drill Guide | LARGE | In distribution |
| Drill Guide | In distribution | |
| Trial Glenoid | STD +2mm | In distribution |
| Trial Glenosphere | Dia. 40 mm | In distribution |
| Trial Glenoid | STD LOW +2mm | In distribution |
| K-Wire Positioning Jig | In distribution | |
| 9013.79.548 | LARGE | In distribution |
| Trial Glenoid | SMALL +2mm | In distribution |
| Cement Compactor | LARGE | In distribution |
| Glenosphere Extraction Insert | Dia. 40 mm | In distribution |
| Glenosphere Extraction Insert | Dia. 36 mm | In distribution |
| Compactor | S | In distribution |
| Cement Compactor | SMALL | In distribution |
| Removal Guide | LARGE | In distribution |
| Glenoid Pusher | In distribution | |
| Trial Glenosphere | Dia. 36 mm | In distribution |
| 9013.79.546 | SMALL | In distribution |
| Glenoid Positioner | STD | In distribution |
| Glenoid Reamer | In distribution | |
| Trial Glenoid | LARGE +2mm | 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
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 |
|---|---|---|---|---|---|---|
| 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 |
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.