CRF II – Radial Prosthesis
Radial Stem
3manufacturers in China registered for this device type
3catalogue 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 6.5 to 19 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DTJ008 | Outer Diameter 8 mm | In distribution |
| DTJ006 | Outer Diameter 6.5 mm | In distribution |
| DTJ019 | Outer Diameter 19 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.