RHS – Radial Prosthesis
9 catalogue numbers from DTJ303, listed by Tornier Inc., United States, under Prosthesis, Elbow, Hemi-, Radial, Polymer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
9catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2025-09-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 6 to 26 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DTJ303 | Outer Diameter 22 mm | In distribution |
| DTJ105 | Outer Diameter 8 mm | In distribution |
| DTJ320 | Outer Diameter 10 mm | In distribution |
| DTJ101 | Outer Diameter 8 mm | In distribution |
| DTJ306 | Outer Diameter 6 mm | In distribution |
| DTJ305 | Outer Diameter 26 mm | In distribution |
| DTJ301 | Outer Diameter 18 mm | In distribution |
| DTJ304 | Outer Diameter 24 mm | In distribution |
| DTJ102 | Outer Diameter 6.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| L2L™ | Zimmer, Inc. | 48 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K994041 | 2000-08-31 |
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.