Tornier Perform Humeral System
Fracture AP Screw Targeting Module
6manufacturers in China registered for this device type
119catalogue 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 | 2022-12-21 |
| Record revised | 2023-10-04 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 | Length 90 to 210 mm; height 13 to 27 mm; outer diameter 37 to 56 mm; angle 135 to 140 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PFX09210S | Size 9S | In distribution |
| IFX217 | Size: 17 | In distribution |
| IFX207S | Length 130 mm | In distribution |
| IFX16 | Size: 16 | In distribution |
| MWX011 | Size 1 | In distribution |
| IFX512 | Size: 12 | In distribution |
| IFX511 | Size: 11 | In distribution |
| IFX510 | Length 210 mm | In distribution |
| IFX309 | Size: 9 | In distribution |
| IFX408 | Length 170 mm | In distribution |
| DWT5219 | Height 19 mm | In distribution |
| MWX101 | In distribution | |
| MWM035 | In distribution | |
| MWX3PL | Size 3+, Long | In distribution |
| MWM001 | 135 EM | In distribution |
| MWX3PS | Size 3+, Standard | In distribution |
| IFX514 | Length 210 mm | In distribution |
| MWM061 | Size 1 | In distribution |
| MWX1PL | Size 1+, Long | In distribution |
| DWN5622 | Height 22 mm | In distribution |
| IFX309S | Size: 9S | In distribution |
| IFX508 | Length 210 mm | In distribution |
| IFX312 | Size: 12 | In distribution |
| IFX801 | In distribution | |
| IFX07 | Size: 7 | In distribution |
| IFX700 | In distribution | |
| IFX10 | Size: 10 | In distribution |
| IFX20990 | Length 90 mm | In distribution |
| MWM021 | Size 1 | In distribution |
| IFX816 | In distribution | |
| DWN3913 | Outer Diameter 39 mm | In distribution |
| MWM016 | In distribution | |
| IFX409 | Length 170 mm | In distribution |
| IFX816S | Size: S | In distribution |
| DWN5019 | Type: CoCr | In distribution |
| IFX11 | Size: 11 | In distribution |
| IFX720 | In distribution | |
| DWT5427 | Outer Diameter 54 mm | In distribution |
| DWN4816 | Type: CoCr | In distribution |
| IFX09 | Size: 9S/9 | In distribution |
| MWX100 | In distribution | |
| MWX013 | Size 3 | In distribution |
| MWX010 | In distribution | |
| IFX13 | Size: 13 | In distribution |
| DWN4617 | Type: CoCr | In distribution |
| DWT4615 | Outer Diameter 46 mm | In distribution |
| MWX1SS | Size 1, Standard | In distribution |
| MWX4SS | Size 4, Standard | In distribution |
| IFX412 | Length 170 mm | In distribution |
| IFX800 | In distribution | |
| PFX12170 | LONG | In distribution |
| IFX411 | Size: 11 | In distribution |
| IFX216 | Size: 16 | In distribution |
| IFX215 | Size: 15 | In distribution |
| IFX209S | Size: 9S/9 | In distribution |
| MWX340 | Size 3 / 4 | In distribution |
| MWM062 | Size 2 | In distribution |
| MWX2SS | Size 2, Standard | In distribution |
| IFX210 | Length 130 mm | In distribution |
| IFX211 | Size: 11 | In distribution |
| IFX815 | Angle 140 ° | In distribution |
| IFX314 | Size: 14 | In distribution |
| IFX15 | Size: 15 | In distribution |
| MWX4PS | Size 4+, Standard | In distribution |
| IFX727 | In distribution | |
| MWM022 | Size 2 | In distribution |
| IFX900 | In distribution | |
| IFX310 | Size: 10 | In distribution |
| IFX413 | Size: 13 | In distribution |
| MWX120 | Size 1 / 2 | In distribution |
| DWT3713 | Type: Ti | In distribution |
| IFX509 | Size: 9S/9 | In distribution |
| IFX726 | In distribution | |
| IFX315 | Size: 15 | In distribution |
| IFX308S | Size: 8S | In distribution |
| MWM023 | Size 3 | In distribution |
| PFX15170 | LONG | In distribution |
| MWX3SX | Size 3, Extra Long | In distribution |
| DWN4116 | Type: CoCr | In distribution |
| IFX414 | Length 170 mm | In distribution |
| DWN4314 | Outer Diameter 43 mm | In distribution |
| MWX1PS | Size 1+, Standard | In distribution |
| MWM063 | Size 3 | In distribution |
| MWM024 | Size 4 | In distribution |
| IFX207S90 | Size: 7S | In distribution |
| DWT120 | Offset: HIGH (+3.5) | In distribution |
| DWT110 | Offset: LOW (+1.5) | In distribution |
| IFX14 | Size: 14 | In distribution |
| IFX212 | Size: 12 | In distribution |
| MWX2PS | Size 2+, Standard | In distribution |
| PFX16130 | Length 130 mm | In distribution |
| IFX214 | Size: 14 | In distribution |
| IFX209 | Size: 9 | In distribution |
| MWM067 | In distribution | |
| IFX415 | Length 170 mm | In distribution |
| MWX3SS | Size 3, Standard | In distribution |
| IFX410 | Size: 10 | In distribution |
| IFX311 | Size: 11 | In distribution |
| PFX00003 | In distribution | |
| IFX513 | Length 210 mm | In distribution |
| IFX12 | Size: 12 | In distribution |
| IFX313 | Size: 13 | In distribution |
| MWM064 | Size 4 | In distribution |
| PFX08130S | Size 8S | In distribution |
| DWN5219 | Outer Diameter 52 mm | In distribution |
| MWX4PL | Size 4+, Long | In distribution |
| DWT4318 | Height 18 mm | In distribution |
| DWT4816 | Outer Diameter 48 mm | In distribution |
| MWX2PL | Size 2+, Long | In distribution |
| MWX014 | Size 4 | In distribution |
| MWX2SX | Size 2, Extra Long | In distribution |
| IFX515 | Length 210 mm | In distribution |
| IFX208S | Size: 8S | In distribution |
| IFX17 | Size: 17 | In distribution |
| MWX135 | Angle 135 ° | In distribution |
| MWX012 | Size 2 | In distribution |
| IFX08 | Size: 8 | In distribution |
| IFX213 | Size: 13 | In distribution |
| DWN4115 | Height 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| 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 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| 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.