Sirius®
6 catalogue numbers from 31-149132, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | PBI |
| Device type | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3310 |
| 510(k) | K130610 |
| Record published | 2020-12-19 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-149132 | Size B | In distribution |
| 31-149103 | SIZE C | In distribution |
| 31-149133 | SIZE C | In distribution |
| 31-149136 | Size F | In distribution |
| 31-149101 | Size A | In distribution |
| 31-149102 | SIZE B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G7® | Biomet Orthopedics | 45 |
| G7 Acetabular Liner | Biomet Orthopedics | 37 |
| Arcos® One-Piece Revision System | Biomet Orthopedics | 17 |
| G7® Acetabular System | Biomet Orthopedics | 13 |
| G7 Osseoti Acetabular Shell | Biomet Orthopedics | 8 |
| G7® Revision Acetabular System | Zimmer, Inc. | 5 |
| G7 Provisional Neutral Liner | Biomet Orthopedics | 4 |
| Echo BI-Metric Microplasty HIP Stem | Biomet Orthopedics | 4 |
| G7® Freedom® Vivacit-E® | Zimmer, Inc. | 4 |
| Sirius HIP System | Biomet Orthopedics | 3 |
| G7 Type 12 / 14 Provisional Head | Biomet Orthopedics | 3 |
| Echo BI-Metric Microplasty HIP System | Biomet Orthopedics | 3 |
Showing 12 of 34. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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 | 2014-12-02 | Class II | Mixed-up of materials/components | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B Catalog Number: 51-199333, Lot Number | 9 | 2015-10-27 |
| Biomet, Inc. | 510(k) number | 2014-12-02 | Class II | Mixed-up of materials/components | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348 Catalog Number: 51-199333, Lot Number I | 8 | 2015-10-27 |
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.