Sidus® Stem-Free Shoulder
39 catalogue numbers from 01.04555.660, listed by Zimmer, Inc., United States, under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
39catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | PKC |
| Device type | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2018-01-30 |
| Record revised | 2021-11-10 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 01.04555.660 | 2 | In distribution | |
| 01.04555.700 | In distribution | ||
| 01.04555.670 | In distribution | ||
| 01.04555.600 | In distribution | ||
| 01.04555.520 | 52-19 | In distribution | |
| 01.04555.850 | In distribution | ||
| 01.04555.505 | 50-21 | In distribution | |
| 01.04555.870 | In distribution | ||
| 01.04555.400 | 40-14 | In distribution | |
| 01.04555.790 | In distribution | ||
| 01.04555.420 | 42-15 | In distribution | |
| 01.04555.120 | M | In distribution | |
| 01.04555.780 | In distribution | ||
| 01.04555.720 | In distribution | ||
| 01.04555.110 | S | In distribution | |
| 01.04555.890 | In distribution | ||
| 01.04555.480 | 48-17 | In distribution | |
| 01.04555.760 | In distribution | ||
| 01.04555.130 | L | In distribution | |
| 01.04555.380 | 38-13 | In distribution | |
| 01.04555.810 | In distribution | ||
| 01.04555.880 | In distribution | ||
| 01.04555.500 | 50-18 | In distribution | |
| 01.04555.820 | In distribution | ||
| 01.04555.860 | In distribution | ||
| 01.04555.440 | 44-16 | In distribution | |
| 01.04555.710 | In distribution | ||
| 01.04555.460 | 46-16 | In distribution | |
| 01.04555.680 | In distribution | ||
| 01.04555.690 | In distribution | ||
| 01.04555.900 | In distribution | ||
| 01.04555.485 | 48-20 | In distribution | |
| 01.04555.740 | In distribution | ||
| 01.04555.750 | In distribution | ||
| 01.04555.800 | In distribution | ||
| 01.04555.770 | In distribution | ||
| 01.04555.525 | 52-23 | In distribution | |
| 01.04555.840 | In distribution | ||
| 01.04555.730 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Comprehensive® Shoulder System | Biomet Orthopedics | 83 |
| Equinoxe | Exactech, Inc. | 60 |
| SMR Stemless | Limacorporate | 51 |
| Global Icon | Depuy (Ireland) | 50 |
| OsseoFit™ Stemless Shoulder | Zimmer, Inc. | 38 |
| DJO Surgical | Encore Medical, L.P. | 32 |
| Tornier Simpliciti® Shoulder System | Tornier Inc. | 27 |
| Simpliciti™ | Tornier Inc. | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Tornier Perform | Tornier Inc. | 10 |
| FX V135 | Fx Solutions | 10 |
| Inhance | Depuy (Ireland) | 5 |
Showing 12 of 19. All products under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241873 | 2024-12-11 |
| K171858 | 2017-12-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | UDI-DI | 2019-08-21 | Class II | Labeling mix-ups | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. | 19 unit worldwide | 2020-07-20 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
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.