Tornier Simpliciti® Shoulder System
Nucleus
2manufacturers in China registered for this device type
27catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Tornier 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K143552 |
| Record published | 2022-04-25 |
| Record revised | 2025-03-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 39 to 56 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7122880 | Outer Diameter 44 mm | In distribution |
| 7122888 | Outer Diameter 52 mm | In distribution |
| 7122871 | Outer Diameter 46 mm | In distribution |
| 7122876 | Outer Diameter 52 mm | In distribution |
| 7122873 | Outer Diameter 50 mm | In distribution |
| 7122882 | Thickness 21 mm | In distribution |
| 7122874 | Thickness 19 mm | In distribution |
| DWG401 | Size 1 | In distribution |
| 7122869 | Outer Diameter 41 mm | In distribution |
| DWG403 | Size 3 | In distribution |
| 7122879 | Thickness 21 mm | In distribution |
| 7122883 | Outer Diameter 48 mm | In distribution |
| 7122884 | Thickness 18 mm | In distribution |
| 7122878 | Outer Diameter 40 mm | In distribution |
| 7122881 | Outer Diameter 44 mm | In distribution |
| 7122891 | Outer Diameter 56 mm | In distribution |
| 7122877 | Outer Diameter 40 mm | In distribution |
| DWG402 | Size 2 | In distribution |
| 7122872 | Thickness 18 mm | In distribution |
| 7122885 | Thickness 21 mm | In distribution |
| 7122875 | Outer Diameter 52 mm | In distribution |
| 7122870 | Outer Diameter 43 mm | In distribution |
| 7122887 | Outer Diameter 52 mm | In distribution |
| 7122889 | Thickness 15 mm | In distribution |
| 7122868 | Outer Diameter 39 mm | In distribution |
| 7122890 | Thickness 18 mm | In distribution |
| 7122886 | Outer Diameter 52 mm | 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 |
| Sidus® Stem-Free Shoulder | Zimmer, Inc. | 39 |
| OsseoFit™ Stemless Shoulder | Zimmer, Inc. | 38 |
| DJO Surgical | Encore Medical, L.P. | 32 |
| 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 |
|---|---|
| K220418 | 2022-09-14 |
| K143552 | 2015-03-04 |
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 |
|---|---|---|---|---|
| 2024-08-29 | Class II | Under Investigation by firm | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). | 5 units |
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.