Aequalis™ PerFORM+ Reversed
34 catalogue numbers from DWJ512, 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
34catalogue 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 |
| Record published | 2016-11-21 |
| Record revised | 2026-02-12 (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, serial number |
| Sizes | Outer diameter 5 to 42 mm; length 7 to 54 mm; angle 15 to 35 ° |
| Distribution end date | 2022-05-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DWJ512 | Outer Diameter 29 mm | Withdrawn |
| DWJ645 | Length 45 mm | Withdrawn |
| DWJ250 | Outer Diameter 9.5 mm | Withdrawn |
| DWJ754 | Length 54 mm | Withdrawn |
| DWJ513 | Outer Diameter 29 mm | Withdrawn |
| DWJ338 | Outer Diameter 5.0 mm | Withdrawn |
| DWJ530 | Outer Diameter 6.5 mm | Withdrawn |
| DWJ330 | Length 30 mm | Withdrawn |
| DWJ411 | Outer Diameter 29 mm | Withdrawn |
| DWJ318 | Length 18 mm | Withdrawn |
| DWJ322 | Length 22 mm | Withdrawn |
| DWJ625 | Outer Diameter 9.5 mm | Withdrawn |
| DWJ734 | Length 34 mm | Withdrawn |
| DWJ504 | Angle 35 ° | Withdrawn |
| DWJ346 | Length 46 mm | Withdrawn |
| DWJ350 | Length 50 mm | Withdrawn |
| DWJ024 | Outer Diameter 42 mm | Withdrawn |
| DWJ130 | Length 30 mm | Withdrawn |
| DWJ032 | Outer Diameter 36 mm | Withdrawn |
| DWJ001 | Length 7 mm | Withdrawn |
| DWJ326 | Length 26 mm | Withdrawn |
| DWJ235 | Outer Diameter 9.5 mm | Withdrawn |
| DWJ033 | Outer Diameter 39 mm | Withdrawn |
| DWJ012 | Outer Diameter 36 mm | Withdrawn |
| DWJ354 | Outer Diameter 5.0 mm | Withdrawn |
| DWJ714 | Outer Diameter 5.0 mm | Withdrawn |
| DWJ021 | Outer Diameter 33 mm | Withdrawn |
| DWJ135 | Length 35 mm | Withdrawn |
| DWJ535 | Outer Diameter 6.5 mm | Withdrawn |
| DWJ314 | Outer Diameter 5.0 mm | Withdrawn |
| DWJ750 | Outer Diameter 5.0 mm | Withdrawn |
| DWJ505 | Angle 15 ° | Withdrawn |
| DWJ401 | Outer Diameter 25 mm | Withdrawn |
| DWJ540 | Outer Diameter 6.5 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
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.