Perform™ Humeral System
47 catalogue numbers from MWX1SS, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
47catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-11-12 |
| Record revised | 2026-02-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 39 to 56 mm; height 13 to 26 mm; angle 135 ° |
| Distribution end date | 2022-04-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MWX1SS | Size SIZE 1 | Withdrawn |
| DWT5424 | Outer Diameter 54 mm | Withdrawn |
| MWX3PL | Size SIZE 3+ | Withdrawn |
| MWX012 | Size SIZE 2 | Withdrawn |
| DWT3914 | Outer Diameter 39 mm | Withdrawn |
| MWX2PL | Size SIZE 2+ | Withdrawn |
| MWX101 | Withdrawn | |
| MWM064 | Withdrawn | |
| MWX013 | Size SIZE 3 | Withdrawn |
| MWM063 | Withdrawn | |
| DWT4619 | Outer Diameter 46 mm | Withdrawn |
| MWX3PS | Size SIZE 3+ | Withdrawn |
| MWX014 | Size SIZE 4 | Withdrawn |
| MWX1PS | Size SIZE 1+ | Withdrawn |
| DWN4818 | Height 18 mm | Withdrawn |
| MWM061 | Withdrawn | |
| MWX3SX | Size SIZE 3 | Withdrawn |
| MWX1PL | Size SIZE 1+ | Withdrawn |
| MWM024 | Withdrawn | |
| MWM035 | Withdrawn | |
| MWX010 | Withdrawn | |
| DWT5016 | Outer Diameter 50 mm | Withdrawn |
| MWX4PS | Size SIZE 4+ | Withdrawn |
| MWX011 | Size SIZE 1 | Withdrawn |
| MWX4SS | Size SIZE 4 | Withdrawn |
| DWN5622 | Outer Diameter 56 mm | Withdrawn |
| MWM062 | Withdrawn | |
| DWT3913 | Outer Diameter 39 mm | Withdrawn |
| MWX2SX | Size SIZE 2 | Withdrawn |
| MWX2SS | Size SIZE 2 | Withdrawn |
| MWM001 | Withdrawn | |
| MWX4PL | Size SIZE 4+ | Withdrawn |
| MWM022 | Withdrawn | |
| MWX2PS | Size SIZE 2+ | Withdrawn |
| DWN5022 | Height 22 mm | Withdrawn |
| MWM021 | Withdrawn | |
| MWX340 | Size SIZE 3/4 | Withdrawn |
| MWM016 | Withdrawn | |
| DWN4816 | Outer Diameter 48 mm | Withdrawn |
| MWM067 | Withdrawn | |
| MWM023 | Withdrawn | |
| MWX120 | Size SIZE 1/2 | Withdrawn |
| MWX100 | Withdrawn | |
| DWT4615 | Height 15 mm | Withdrawn |
| MWX3SS | Size SIZE 3 | Withdrawn |
| DWN5226 | Outer Diameter 52 mm | Withdrawn |
| MWX135 | Angle 135 ° | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
| Catalyst CSR Shoulder System | Catalyst Orthoscience Inc | 39 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251686 | 2025-10-30 |
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.