Explor
32 catalogue numbers from 11-210060, listed by Biomet Orthopedics, 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
32catalogue 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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| 510(k) | K040611 |
| Record published | 2015-10-24 |
| Record revised | 2025-07-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-210060 | 5MM Ø 22MM LENGTH | In distribution |
| 11-210063 | 8MM Ø 28MM LENGTH | In distribution |
| 11-210017 | 20MM HEIGHT 18MM Ø | In distribution |
| 11-210012 | 10MM HEIGHT 18MM Ø | In distribution |
| 11-210032 | 12MM HEIGHT 22MM Ø | In distribution |
| 11-210041 | 10MM HEIGHT 24MM Ø | In distribution |
| 11-210022 | 10MM HEIGHT 20MM Ø | In distribution |
| 11-210023 | 12MM HEIGHT 20MM Ø | In distribution |
| 11-210021 | 8MM HEIGHT 20MM Ø | In distribution |
| 11-210043 | 14MM HEIGHT 24MM Ø | In distribution |
| 11-210024 | 14MM HEIGHT 20MM Ø | In distribution |
| 11-210062 | 7MM Ø 26MM LENGTH | In distribution |
| 11-210064 | 9MM Ø 30MM LENGTH | In distribution |
| 11-210015 | 16MM HEIGHT 18MM Ø | In distribution |
| 11-210027 | 20MM HEIGHT 20MM Ø | In distribution |
| 11-210025 | 16MM HEIGHT 20MM Ø | In distribution |
| 11-210016 | 18MM HEIGHT 18MM Ø | In distribution |
| 11-210031 | 10MM HEIGHT 22MM Ø | In distribution |
| 11-210045 | 18MM HEIGHT 24MM Ø | In distribution |
| 11-210033 | 14MM HEIGHT 22MM Ø | In distribution |
| 11-210036 | 20MM HEIGHT 22MM Ø | In distribution |
| 11-210061 | 6MM Ø 24MM LENGTH | In distribution |
| 11-210011 | 8MM HEIGHT 18MM Ø | In distribution |
| 11-210013 | 12MM HEIGHT 18MM Ø | In distribution |
| 11-210099 | In distribution | |
| 11-210035 | 18MM HEIGHT 22MM Ø | In distribution |
| 11-210014 | 14MM HEIGHT 18MM Ø | In distribution |
| 11-210044 | 16MM HEIGHT 24MM Ø | In distribution |
| 11-210042 | 12MM HEIGHT 24MM Ø | In distribution |
| 11-210065 | 10MM Ø 32MM LENGTH | In distribution |
| 11-210034 | 16MM HEIGHT 22MM Ø | In distribution |
| 11-210026 | 18MM HEIGHT 20MM Ø | 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 |
| 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
2 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2017-06-16 | Class II | Packaging change control | Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem. | 2018-09-06 | |
| Biomet, Inc. | 510(k) number | 2014-04-22 | Class II | Process control | This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the se | 8 devices | 2015-01-13 |
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.