G7® Freedom® Vivacit-E®
The G7 Freedom Vivacit-E Constrained Liner is an acetabular bearing used in total hip replacement. It is intended for primary or revision patients at high risk of dislocation after other…
The G7 Freedom Vivacit-E Constrained Liner is an acetabular bearing used in total hip replacement. It is intended for primary or revision patients at high risk of dislocation after other options for constrained acetabular components have been considered.
The liner uses vitamin E-infused, highly crosslinked ultra-high molecular weight polyethylene within the compatible G7 acetabular system. Its constraining ring forms part of the design that retains the femoral head within the bearing.
Patient Selection
Risk factors include previous dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or instability found during surgery. Component selection and assembly must match the compatible total hip system.
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 | Zimmer, Inc., 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 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K212512 |
| Record published | 2022-05-17 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 32 to 36 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30203605 | Lumen/Inner Diameter 36.00 mm | In distribution |
| 30213202 | 10°, Size B | In distribution |
| 30213604 | Lumen/Inner Diameter 36.00 mm | In distribution |
| 30213203 | 10°, Size C | 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 |
| Sirius® | Biomet Orthopedics | 6 |
| G7® Revision Acetabular System | Zimmer, Inc. | 5 |
| G7 Provisional Neutral Liner | Biomet Orthopedics | 4 |
| Echo BI-Metric Microplasty HIP Stem | Biomet Orthopedics | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212512 | 2022-04-28 |
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.