Prosthesis, Elbow, Hemi-, Radial, Polymer
Offset Stem Inserter/Extractor FOR Radial Head Prosthesis
3manufacturers in China registered for this device type
43catalogue numbers in this listing
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K183618 |
| Record published | 2020-06-08 |
| Record revised | 2024-09-11 (version 9) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09.405.260S | In distribution | |
| 09.405.586S | In distribution | |
| 09.405.276S | In distribution | |
| 03.402.717 | In distribution | |
| 03.402.722 | In distribution | |
| 09.405.253S | In distribution | |
| 09.405.963S | In distribution | |
| 03.402.719 | In distribution | |
| 03.402.720 | In distribution | |
| 09.405.583S | In distribution | |
| 09.405.966S | In distribution | |
| 09.405.566S | In distribution | |
| 09.405.950S | In distribution | |
| 03.402.740 | In distribution | |
| 09.405.263S | In distribution | |
| 09.405.960S | In distribution | |
| 09.405.573S | In distribution | |
| 03.402.718 | In distribution | |
| 09.405.250S | In distribution | |
| 09.405.280S | In distribution | |
| 09.405.956S | In distribution | |
| 09.405.563S | In distribution | |
| 09.405.560S | In distribution | |
| 03.402.723 | In distribution | |
| 03.402.741 | In distribution | |
| 03.402.725 | In distribution | |
| 09.405.580S | In distribution | |
| 09.405.273S | In distribution | |
| 03.405.000S | In distribution | |
| 09.405.976S | In distribution | |
| 09.405.256S | In distribution | |
| 03.402.721 | In distribution | |
| 03.402.716 | In distribution | |
| 09.405.953S | In distribution | |
| 09.405.576S | In distribution | |
| 09.405.973S | In distribution | |
| 09.405.970S | In distribution | |
| 09.405.286S | In distribution | |
| 09.405.266S | In distribution | |
| 09.405.270S | In distribution | |
| 09.405.283S | In distribution | |
| 03.402.724 | In distribution | |
| 09.405.570S | 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 |
| 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 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2022-04-07 | Class II | Labeling Change Control | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. | ||
| Synthes (USA) Products LLC | 510(k) number | 2016-12-29 | Class II | Under Investigation by firm | There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. | 50,311 units | 2018-02-06 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-02-22 | Class II | Device Design | The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events. | 417 | 2015-08-31 |
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.