Aequalis™ Fx2
33 catalogue numbers from DWH413B, 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
33catalogue 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 |
| 510(k) | K141345 |
| Record published | 2015-10-16 |
| Record revised | 2018-09-07 (version 4) |
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 7 to 42 mm; length 90 to 210 mm; angle 12.5 ° |
| Distribution end date | 2017-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DWH413B | Length 130 mm | Withdrawn |
| DWK271B | Outer Diameter 42 mm | Withdrawn |
| DWK145B | Outer Diameter 13 mm | Withdrawn |
| DWK251B | Angle 12.5 ° | Withdrawn |
| DWH434B | Outer Diameter 11 mm | Withdrawn |
| DWK266B | Outer Diameter 36 mm | Withdrawn |
| DWK126B | Length 130 mm | Withdrawn |
| DWH441B | Thickness +6 mm | Withdrawn |
| DWK133B | Length 170 mm | Withdrawn |
| DWK264B | Outer Diameter 36 mm | Withdrawn |
| DWK112B | Length 90 mm | Withdrawn |
| DWH406B | Length 90 mm | Withdrawn |
| DWH564B | Thickness +6 mm | Withdrawn |
| DWH414B | Length 130 mm | Withdrawn |
| DWH435B | Outer Diameter 13 mm | Withdrawn |
| DWK132B | Outer Diameter 9 mm | Withdrawn |
| DWK114B | Outer Diameter 11 mm | Withdrawn |
| DWH444B | Outer Diameter 36 mm | Withdrawn |
| DWK115B | Outer Diameter 13 mm | Withdrawn |
| DWH421B | Outer Diameter 7 mm | Withdrawn |
| DWH425B | Length 170 mm | Withdrawn |
| DWK232B | Outer Diameter 42 mm | Withdrawn |
| DWH562B | Outer Diameter 42 mm | Withdrawn |
| DWH445B | Thickness +9 mm | Withdrawn |
| DWK111B | Outer Diameter 7 mm | Withdrawn |
| DWK224B | Angle 12.5 ° | Withdrawn |
| DWK225B | Angle 12.5 ° | Withdrawn |
| DWH465B | Outer Diameter 42 mm | Withdrawn |
| DWK244B | Outer Diameter 36 mm | Withdrawn |
| DWK134B | Length 170 mm | Withdrawn |
| DWK231B | Thickness +9 mm | Withdrawn |
| DWK205B | Outer Diameter 36 mm | Withdrawn |
| DWK113B | Length 90 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 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Tornier Inc. | 510(k) number | 2016-09-19 | Class II | Component design/selection | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. | 30 | 2018-05-31 |
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.