Affiniti™
25 catalogue numbers from 0020015, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
25catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Tornier Inc., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2023-10-12 (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 | lot or batch number, expiry date |
| Sizes | Outer diameter 6 to 56 mm; length 110 to 220 mm |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0020015 | Length 220 mm | Withdrawn |
| 0020045 | Outer Diameter 44 mm | Withdrawn |
| 0020014 | Length 110 mm | Withdrawn |
| 0020012 | Outer Diameter 12 mm | Withdrawn |
| 0020021 | Outer Diameter 40 mm | Withdrawn |
| 0020026 | Thickness 21 mm | Withdrawn |
| 0020052 | Outer Diameter 52 mm | Withdrawn |
| 0020044 | Thickness 15 mm | Withdrawn |
| 0020056 | Outer Diameter 56 mm | Withdrawn |
| 0020040 | Thickness 15 mm | Withdrawn |
| 0020049 | Outer Diameter 48 mm | Withdrawn |
| 0020042 | Outer Diameter 40 mm | Withdrawn |
| 0020057 | Outer Diameter 56 mm | Withdrawn |
| 0020038 | Thickness 21 mm | Withdrawn |
| 0020029 | Outer Diameter 48 mm | Withdrawn |
| 0020016 | Outer Diameter 16 mm | Withdrawn |
| 0020006 | Outer Diameter 6 mm | Withdrawn |
| 0020009 | Outer Diameter 8 mm | Withdrawn |
| 0020046 | Outer Diameter 44 mm | Withdrawn |
| 0020025 | Thickness 18 mm | Withdrawn |
| 0020053 | Thickness 18 mm | Withdrawn |
| 0020030 | Thickness 21 mm | Withdrawn |
| 0020034 | Thickness 21 mm | Withdrawn |
| 0020037 | Outer Diameter 56 mm | Withdrawn |
| 0020050 | Outer Diameter 48 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| 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 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062661 | 2006-12-22 |
| K063081 | 2006-11-09 |
| K011942 | 2001-07-13 |
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.