Tornier Perform™ Humeral System
VE 10° Reversed Insert, 45%
9manufacturers in China registered for this device type
96catalogue 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) | K241878 |
| Record published | 2022-04-07 |
| Record revised | 2025-02-17 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 33 to 42 mm; length 30 to 210 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DWR1366 | Size: 1 / 2 | In distribution |
| DWR1363 | Size: 1 / 2 | In distribution |
| DWR2360 | Outer Diameter 36 mm | In distribution |
| DWP3360 | Outer Diameter 36 mm | In distribution |
| DWP4426 | Thickness: +6 mm | In distribution |
| DWP3336 | Outer Diameter 33 mm | In distribution |
| DWR4420 | Size: 3 / 4 | In distribution |
| DWR1396 | Size: 1 / 2 | In distribution |
| DWR1333 | Size: 1 / 2 | In distribution |
| DWP1390 | Outer Diameter 39 mm | In distribution |
| DWR3393 | Size: 1 / 2 | In distribution |
| PFX00011 | Thickness 9 mm | In distribution |
| DWR2366 | Thickness: +6 mm | In distribution |
| DWR2393 | Outer Diameter 39 mm | In distribution |
| DWR2420 | Outer Diameter 42 mm | In distribution |
| DWR4360 | Outer Diameter 36 mm | In distribution |
| DWR3333 | Outer Diameter 33 mm | In distribution |
| DWR3330 | Size: 1 / 2 | In distribution |
| ARS1022301 | Outer Diameter 36 mm | In distribution |
| DWP3366 | Thickness: +6 mm | In distribution |
| DWP3363 | Thickness: +3 mm | In distribution |
| PFX00030 | Length 30 mm | In distribution |
| DWR3396 | Outer Diameter 39 mm | In distribution |
| DWR2423 | Size: 3 / 4 | In distribution |
| DWR3336 | Thickness: +6 mm | In distribution |
| DWR3360 | Outer Diameter 36 mm | In distribution |
| DWP4423 | Size: 3 / 4 | In distribution |
| DWR3390 | Size: 1 / 2 | In distribution |
| DWP2360 | Outer Diameter 36 mm | In distribution |
| DWR4363 | Size: 3 / 4 | In distribution |
| DWP2420 | Thickness: +0 mm | In distribution |
| DWP2393 | Outer Diameter 39 mm | In distribution |
| DWP1333 | Thickness: +3 mm | In distribution |
| DWR1336 | Thickness: +6 mm | In distribution |
| DWP1366 | Thickness: +6 mm | In distribution |
| DWP1363 | Thickness: +3 mm | In distribution |
| DWW6420 | Size: 3 / 4 | In distribution |
| DWP4396 | Outer Diameter 39 mm | In distribution |
| DWR4366 | Outer Diameter 36 mm | In distribution |
| ARS1022403 | Size: 3 / 4 | In distribution |
| DWR1390 | Outer Diameter 39 mm | In distribution |
| DWX5330 | Size: 1 / 2 | In distribution |
| DWR4396 | Thickness: +6 mm | In distribution |
| DWR4423 | Size: 3 / 4 | In distribution |
| PFX15130 | Length 130 mm | In distribution |
| DWP4390 | Thickness: +0 mm | In distribution |
| DWP3330 | Thickness: +0 mm | In distribution |
| DWP4360 | Size: 3 / 4 | In distribution |
| DWP1393 | Size: 1 / 2 | In distribution |
| DWR2363 | Thickness: +3 mm | In distribution |
| DWP4420 | Thickness: +0 mm | In distribution |
| DWP2363 | Outer Diameter 36 mm | In distribution |
| PFX14210 | Size 14 | In distribution |
| DWW6363 | Thickness +3 mm | In distribution |
| DWP2423 | Outer Diameter 42 mm | In distribution |
| DWP1396 | Size: 1 / 2 | In distribution |
| DWP1336 | Outer Diameter 33 mm | In distribution |
| DWX6426 | Outer Diameter 42 mm | In distribution |
| DWR1330 | Size: 1 / 2 | In distribution |
| DWP1330 | Thickness: +0 mm | In distribution |
| DWP2426 | Outer Diameter 42 mm | In distribution |
| DWR4390 | Outer Diameter 39 mm | In distribution |
| DWP3333 | Size: 1 / 2 | In distribution |
| DWP2396 | Size: 3 / 4 | In distribution |
| DWR4426 | Outer Diameter 42 mm | In distribution |
| DWR2396 | Size: 3 / 4 | In distribution |
| DWR1360 | Outer Diameter 36 mm | In distribution |
| ARS1022404 | Thickness -2 mm | In distribution |
| DWP3390 | Outer Diameter 39 mm | In distribution |
| DWX934 | Thickness 9 mm | In distribution |
| DWP1360 | Size: 1 / 2 | In distribution |
| DWP4393 | Thickness: +3 mm | In distribution |
| DWW6396 | Thickness +6 mm | In distribution |
| ARS1022409 | Size: 3 / 4 | In distribution |
| ARS1022407 | Size: 3 / 4 | In distribution |
| DWR4393 | Thickness: +3 mm | In distribution |
| DWP3393 | Thickness: +3 mm | In distribution |
| DWP2366 | Thickness: +6 mm | In distribution |
| PFX13170 | LONG | In distribution |
| PFX07130S | Length 130 mm | In distribution |
| DWW6423 | Thickness +3 mm | In distribution |
| DWR3363 | Size: 1 / 2 | In distribution |
| DWR1393 | Outer Diameter 39 mm | In distribution |
| DWX5396 | Outer Diameter 39 mm | In distribution |
| DWR2426 | Thickness: +6 mm | In distribution |
| DWP2390 | Size: 3 / 4 | In distribution |
| DWW6390 | Outer Diameter 39 mm | In distribution |
| DWR3366 | Outer Diameter 36 mm | In distribution |
| DWP4363 | Outer Diameter 36 mm | In distribution |
| DWX6390 | Size: 3 / 4 | In distribution |
| DWW5333 | Thickness +3 mm | In distribution |
| PFX00012 | Thickness 9 mm | In distribution |
| DWP4366 | Outer Diameter 36 mm | In distribution |
| DWR2390 | Outer Diameter 39 mm | In distribution |
| DWW5390 | Thickness +0 mm | In distribution |
| DWP3396 | Size: 1 / 2 | In distribution |
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 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
| Perform™ Humeral System | Tornier Inc. | 74 |
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 UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Tornier Inc. | UDI-DI | 2024-08-29 | Class II | Under Investigation by firm | Devices from one lot of Perform” Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. | 38 units |
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.