BioPoly® Radial Head Implant
BioPoly Radial Head Implant replaces the articular surface and spacing of the proximal radius. It is a hemiarthroplasty component used after fracture, resection or degenerative damage…
BioPoly Radial Head Implant replaces the articular surface and spacing of the proximal radius. It is a hemiarthroplasty component used after fracture, resection or degenerative damage around the elbow.
The implant has a concave spherical articulating surface and separate head-to-stem connection. Its stem is intended for uncemented fixation.
Listed Item
BioPoly® Radial Head Implant, 20 x 8(+6)mm
Size Selection
Head diameters are 20, 23 and 26 mm, with stem diameters from 6 to 9 mm. Height offsets of 0, 3 or 6 mm allow the reconstruction height to be selected. Head and stem choices are matched to the patient’s anatomy.
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 | Biopoly, LLC, United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Manufacturer |
| 510(k) | K233592 |
| Record published | 2025-01-02 |
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 |
|---|---|---|
| 160-5086 | In distribution | |
| 160-5393 | In distribution | |
| 160-5076 | In distribution | |
| 160-5386 | In distribution | |
| 160-5680 | In distribution | |
| 160-5696 | In distribution | |
| 160-5383 | In distribution | |
| 160-5683 | In distribution | |
| 160-5073 | In distribution | |
| 160-5693 | In distribution | |
| 160-5690 | In distribution | |
| 160-5366 | In distribution | |
| 160-5370 | In distribution | |
| 160-5390 | In distribution | |
| 160-5070 | In distribution | |
| 160-5080 | In distribution | |
| 160-5380 | In distribution | |
| 160-5686 | In distribution | |
| 160-5676 | In distribution | |
| 160-5060 | In distribution | |
| 160-5376 | In distribution | |
| 160-5373 | In distribution | |
| 160-5396 | In distribution | |
| 160-5066 | In distribution | |
| 160-5363 | In distribution | |
| 160-5360 | In distribution | |
| 160-5083 | In distribution | |
| 160-5670 | In distribution | |
| 160-5673 | In distribution | |
| 160-5063 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233592 | 2024-03-13 |
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.