Aequalis™ Fx2
37 catalogue numbers from DWK211B, listed by Tornier Inc., United States, under Shoulder Prosthesis, Reverse Configuration. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
37catalogue numbers in this listing
18510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (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 |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K152966 |
| Record published | 2016-01-25 |
| Record revised | 2018-09-07 (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 7 to 42 mm; length 90 to 210 mm; angle 12.5 ° |
| Distribution end date | 2017-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DWK211B | Angle 12.5 ° | Withdrawn |
| DWH432B | Length 210 mm | Withdrawn |
| DWK135B | Outer Diameter 13 mm | Withdrawn |
| DWK121B | Outer Diameter 7 mm | Withdrawn |
| DWH436B | Length 210 mm | Withdrawn |
| DWK265B | Outer Diameter 36 mm | Withdrawn |
| DWH411B | Outer Diameter 7 mm | Withdrawn |
| DWK252B | Outer Diameter 42 mm | Withdrawn |
| DWH423B | Length 170 mm | Withdrawn |
| DWH543B | Outer Diameter 36 mm | Withdrawn |
| DWK143B | Outer Diameter 9 mm | Withdrawn |
| DWK123B | Length 130 mm | Withdrawn |
| DWK230B | Outer Diameter 42 mm | Withdrawn |
| DWH424B | Outer Diameter 11 mm | Withdrawn |
| DWH566B | Outer Diameter 42 mm | Withdrawn |
| DWH405B | Length 90 mm | Withdrawn |
| DWK245B | Angle 12.5 ° | Withdrawn |
| DWH433B | Outer Diameter 9 mm | Withdrawn |
| DWK136B | Length 170 mm | Withdrawn |
| DWK210B | Angle 12.5 ° | Withdrawn |
| DWH422B | Outer Diameter 9 mm | Withdrawn |
| DWH415B | Outer Diameter 13 mm | Withdrawn |
| DWK146B | Length 210 mm | Withdrawn |
| DWH546B | Outer Diameter 36 mm | Withdrawn |
| DWH563B | Outer Diameter 42 mm | Withdrawn |
| DWK212B | Thickness +12 mm | Withdrawn |
| DWH401B | Length 90 mm | Withdrawn |
| DWK270B | Outer Diameter 42 mm | Withdrawn |
| DWH402B | Length 90 mm | Withdrawn |
| DWH545B | Thickness +9 mm | Withdrawn |
| DWH404B | Outer Diameter 11 mm | Withdrawn |
| DWK116B | Outer Diameter 15 mm | Withdrawn |
| DWK142B | Length 210 mm | Withdrawn |
| DWK144B | Outer Diameter 11 mm | Withdrawn |
| DWK246B | Outer Diameter 36 mm | Withdrawn |
| DWK250B | Outer Diameter 42 mm | Withdrawn |
| DWK204B | Outer Diameter 36 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252788 | 2026-01-08 |
| K220914 | 2022-10-14 |
| K211359 | 2021-11-12 |
| K213124 | 2021-10-26 |
| K183696 | 2019-01-30 |
| K161742 | 2016-11-15 |
| K141029 | 2014-06-18 |
| K120739 | 2012-07-05 |
| K112144 | 2012-03-13 |
| K112615 | 2011-10-11 |
| K110599 | 2011-06-14 |
| K100142 | 2010-05-06 |
| K081059 | 2008-07-17 |
| K071948 | 2007-10-18 |
| K061439 | 2006-07-20 |
| K050316 | 2005-03-16 |
| K041873 | 2004-08-25 |
| K030941 | 2004-05-14 |
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 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2024-01-03 | Class II | Packaging process control | The incorrect device is contained in the labeled package. | 50 | |
| 2023-09-15 | Class II | Process change control | One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate. | 30 units | |
| 2019-10-18 | Class II | Package design/selection | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister sh | 87869 units | 2021-04-09 |
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.