Simpliciti™
27 catalogue numbers from 7122871, listed by Tornier 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.
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 |
| Record published | 2015-10-16 |
| Record revised | 2026-02-11 (version 5) |
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, serial number |
| Sizes | Outer diameter 39 to 56 mm |
| Distribution end date | 2022-10-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7122871 | Thickness 17 mm | Withdrawn |
| 7122874 | Thickness 19 mm | Withdrawn |
| 7122872 | Thickness 18 mm | Withdrawn |
| 7122869 | Thickness 15 mm | Withdrawn |
| 7122876 | Thickness 23 mm | Withdrawn |
| 7122891 | Thickness 21 mm | Withdrawn |
| 7122879 | Outer Diameter 40 mm | Withdrawn |
| DWG402 | Size 2 | Withdrawn |
| 7122885 | Thickness 21 mm | Withdrawn |
| 7122868 | Thickness 14 mm | Withdrawn |
| 7122880 | Thickness 15 mm | Withdrawn |
| 7122870 | Outer Diameter 43 mm | Withdrawn |
| 7122884 | Thickness 18 mm | Withdrawn |
| 7122882 | Outer Diameter 44 mm | Withdrawn |
| 7122889 | Thickness 15 mm | Withdrawn |
| 7122875 | Thickness 19 mm | Withdrawn |
| 7122883 | Thickness 15 mm | Withdrawn |
| DWG401 | Size 1 | Withdrawn |
| 7122890 | Thickness 18 mm | Withdrawn |
| 7122877 | Thickness 15 mm | Withdrawn |
| 7122887 | Outer Diameter 52 mm | Withdrawn |
| DWG403 | Size 3 | Withdrawn |
| 7122888 | Thickness 21 mm | Withdrawn |
| 7122886 | Outer Diameter 52 mm | Withdrawn |
| 7122881 | Thickness 18 mm | Withdrawn |
| 7122878 | Thickness 18 mm | Withdrawn |
| 7122873 | Outer Diameter 50 mm | Withdrawn |
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 |
| Tornier Simpliciti® Shoulder System | 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.