Genflex2 Total Knee System
GENflex2 CR Ultra-Congruent Tibial Insert, EXp, Size 2.5-15
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-20 |
| Record revised | 2020-12-11 (version 4) |
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 |
|---|---|---|
| SC3751-4.5 | In distribution | |
| SC3802-2-17 | In distribution | |
| SC3916-1-10 | In distribution | |
| SC3802-5-23 | In distribution | |
| SC3754-1.5-14 | In distribution | |
| SC3803-3.5-23 | In distribution | |
| SC3753-5-14 | In distribution | |
| SC3802-3.5-30 | In distribution | |
| SC3753-3.5-16 | In distribution | |
| SC3753-4.5-10 | In distribution | |
| SC3916-4-15 | In distribution | |
| SC3753-1.5-11 | In distribution | |
| SC3802-3.5-23 | In distribution | |
| SC3753-2-12 | In distribution | |
| SC3752-6 | In distribution | |
| SC3754-2-12 | In distribution | |
| SC3916-3-16 | In distribution | |
| SC3753-6-26 | In distribution | |
| SC3916-2-26 | In distribution | |
| SC3802-2.5-11 | In distribution | |
| SC3916-2.5-15 | In distribution | |
| SC3754-3.5-20 | In distribution | |
| SC3916-2.5-10 | In distribution | |
| SC3858-3.5 | In distribution | |
| SC3753-3.5-14 | In distribution | |
| SC3754-1.5-20 | In distribution | |
| SC3916-4.5-23 | In distribution | |
| SC3753-6-12 | In distribution | |
| SC3916-6-30 | In distribution | |
| SC3754-6-14 | In distribution | |
| SC3754-5-14 | In distribution | |
| SC3916-2-13 | In distribution | |
| SC3802-5-30 | In distribution | |
| SC3916-5-23 | In distribution | |
| SC3754-3.5-10 | In distribution | |
| SC3916-4.5-14 | In distribution | |
| SC3753-2-16 | In distribution | |
| SC3803-3.5-30 | In distribution | |
| SC3916-3.5-26 | In distribution | |
| SC3754-4-12 | In distribution | |
| SC3916-2.5-11 | In distribution | |
| SC3754-5-20 | In distribution | |
| SC3803-1-15 | In distribution | |
| SC3802-1-12 | In distribution | |
| SC3802-1.5-10 | In distribution | |
| SC3916-6-17 | In distribution | |
| SC3916-4-10 | In distribution | |
| SC3916-4.5-20 | In distribution | |
| SC3802-3.5-15 | In distribution | |
| SC3803-6-13 | In distribution | |
| SC3916-6-13 | In distribution | |
| SC3916-5-20 | In distribution | |
| SC3802-6-15 | In distribution | |
| SC3753-4.5-26 | In distribution | |
| SC3754-6-26 | In distribution | |
| SC3754-4-16 | In distribution | |
| SC3749-2.5 | In distribution | |
| SC3802-4-11 | In distribution | |
| SC3916-1-15 | In distribution | |
| SC3754-4-20 | In distribution | |
| SC3916-6-16 | In distribution | |
| SC3754-3-14 | In distribution | |
| SC3753-2.5-14 | In distribution | |
| SC3803-1.5-15 | In distribution | |
| SC3750-1.5 | In distribution | |
| SC3802-3.5-17 | In distribution | |
| SC3916-2.5-20 | In distribution | |
| SC3754-3-16 | In distribution | |
| SC3802-4.5-30 | In distribution | |
| SC3802-1.5-12 | In distribution | |
| SC3802-4-15 | In distribution | |
| SC3753-2.5-16 | In distribution | |
| SC3803-2.5-14 | In distribution | |
| SC3916-4.5-10 | In distribution | |
| SC3802-4-13 | In distribution | |
| SC3916-5-11 | In distribution | |
| SC3752-4.5 | In distribution | |
| SC3916-1-14 | In distribution | |
| SC3916-1-20 | In distribution | |
| SC3916-1-12 | In distribution | |
| SC3916-1.5-15 | In distribution | |
| SC3803-5-23 | In distribution | |
| SC3802-1-30 | In distribution | |
| SC3802-2-30 | In distribution | |
| SC3802-2.5-30 | In distribution | |
| SC3916-3.5-20 | In distribution | |
| SC3916-3.5-12 | In distribution | |
| SC3803-3.5-11 | In distribution | |
| SC3857-3.5 | In distribution | |
| SC3916-3-11 | In distribution | |
| SC3754-1-14 | In distribution | |
| SC3916-1.5-26 | In distribution | |
| SC3753-1-11 | In distribution | |
| SC3754-5-12 | In distribution | |
| SC3753-5-20 | In distribution | |
| SC3916-3-26 | In distribution | |
| SC3916-4.5-16 | In distribution | |
| SC3916-5-13 | In distribution | |
| SC3754-2-14 | In distribution | |
| SC3753-4-14 | In distribution | |
| SC3916-2-30 | In distribution | |
| SC3802-1.5-26 | In distribution | |
| SC3916-3-20 | In distribution | |
| SC3803-1-23 | In distribution | |
| SC3754-4.5-14 | In distribution | |
| SC3803-3-30 | In distribution | |
| SC3803-6-23 | In distribution | |
| SC3916-1.5-11 | In distribution | |
| SC3916-4-16 | In distribution | |
| SC3754-1-12 | In distribution | |
| SC3803-3.5-17 | In distribution | |
| SC3754-2.5-14 | In distribution | |
| SC3803-5-15 | In distribution | |
| SC3803-4.5-13 | In distribution | |
| SC3802-1-14 | In distribution | |
| SC3751-3.5 | In distribution | |
| SC3803-2-13 | In distribution | |
| SC3753-3.5-12 | In distribution | |
| SC3749-6 | In distribution | |
| SC3802-4.5-23 | In distribution | |
| SC3916-3-15 | In distribution | |
| SC3753-3.5-20 | In distribution | |
| SC3749-4.5 | In distribution | |
| SC3753-2-20 | In distribution | |
| SC3802-5-17 | In distribution | |
| SC3802-1.5-16 | In distribution | |
| SC3803-4-11 | In distribution | |
| SC3754-3.5-16 | In distribution | |
| SC3752-3.5 | In distribution | |
| SC3858-2.5 | In distribution | |
| SC3802-4.5-13 | In distribution | |
| SC3753-2.5-12 | In distribution | |
| SC3803-2-17 | In distribution | |
| SC3802-1-10 | In distribution | |
| SC3754-1-16 | In distribution | |
| SC3802-3-13 | In distribution | |
| SC3754-1.5-12 | In distribution | |
| SC3753-3-10 | In distribution | |
| SC3802-3-23 | In distribution | |
| SC3754-1-26 | In distribution | |
| SC3803-1.5-23 | In distribution | |
| SC3916-1.5-23 | In distribution | |
| SC3751-2.5 | In distribution | |
| SC3752-1.5 | In distribution | |
| SC3802-6-13 | In distribution | |
| SC3802-4.5-15 | In distribution | |
| SC3916-1.5-10 | In distribution | |
| SC3916-3.5-13 | In distribution | |
| SC3916-1-26 | In distribution | |
| SC3802-2-11 | In distribution | |
| SC3754-3-20 | In distribution | |
| SC3753-4-12 | In distribution | |
| SC3802-2-23 | In distribution | |
| SC3753-5-26 | In distribution | |
| SC3802-3-15 | In distribution | |
| SC3803-2-15 | In distribution | |
| SC3857-4.5 | In distribution | |
| SC3753-4.5-20 | In distribution | |
| SC3916-1.5-17 | In distribution | |
| SC3753-3-16 | In distribution | |
| SC3803-6-15 | In distribution | |
| SC3803-2-23 | In distribution | |
| SC3754-4.5-12 | In distribution | |
| SC3754-4.5-20 | In distribution | |
| SC3753-6-20 | In distribution | |
| SC3753-1-13 | In distribution | |
| SC3803-2.5-16 | In distribution | |
| SC3803-1.5-30 | In distribution | |
| SC3803-4.5-17 | In distribution | |
| SC3857-2.5 | In distribution | |
| SC3754-2.5-26 | In distribution | |
| SC3916-2-12 | In distribution | |
| SC3754-1-20 | In distribution | |
| SC3916-3.5-30 | In distribution | |
| SC3753-5-12 | In distribution | |
| SC3802-3-30 | In distribution | |
| SC3753-4.5-16 | In distribution | |
| SC3803-1.5-11 | In distribution | |
| SC3803-5-11 | In distribution | |
| SC3754-2.5-12 | In distribution | |
| SC3753-4-10 | In distribution | |
| SC3753-4.5-12 | In distribution | |
| SC3916-6-20 | In distribution | |
| SC3916-6-23 | In distribution | |
| SC3916-4.5-26 | In distribution | |
| SC3753-1.5-15 | In distribution | |
| SC3753-4-26 | In distribution | |
| SC3803-2.5-11 | In distribution | |
| SC3916-4.5-11 | In distribution | |
| SC3749-1 | In distribution | |
| SC3751-6 | In distribution | |
| SC3916-3.5-11 | In distribution | |
| SC3916-2-20 | In distribution | |
| SC3916-3-10 | In distribution | |
| SC3752-2.5 | In distribution | |
| SC3916-1-13 | In distribution | |
| SC3802-1-23 | In distribution | |
| SC3754-4-10 | In distribution | |
| SC3803-1-30 | In distribution | |
| SC3916-6-14 | In distribution | |
| SC3803-3.5-15 | In distribution | |
| SC3916-1-23 | In distribution | |
| SC3754-5-16 | In distribution | |
| SC3802-6-30 | In distribution | |
| SC3803-6-30 | In distribution | |
| SC3802-2.5-15 | In distribution | |
| SC3916-1-16 | In distribution | |
| SC3753-6-16 | In distribution | |
| SC3802-4.5-11 | In distribution | |
| SC3803-5-30 | In distribution | |
| SC3753-5-16 | In distribution | |
| SC3802-2-15 | In distribution | |
| SC3858-4.5 | In distribution | |
| SC3803-1-17 | In distribution | |
| SC3803-1-11 | In distribution | |
| SC3916-5-14 | In distribution | |
| SC3803-2.5-26 | In distribution | |
| SC3916-2-10 | In distribution | |
| SC3751-1.5 | In distribution | |
| SC3916-2.5-30 | In distribution | |
| SC3754-2-26 | In distribution | |
| SC3754-6-20 | In distribution | |
| SC3754-3-12 | In distribution | |
| SC3916-3.5-10 | In distribution | |
| SC3916-6-26 | In distribution | |
| SC3753-1.5-23 | In distribution | |
| SC3802-6-17 | In distribution | |
| SC3802-2.5-23 | In distribution | |
| SC3803-4-17 | In distribution | |
| SC3916-2-14 | In distribution | |
| SC3916-2-15 | In distribution | |
| SC3754-3-26 | In distribution | |
| SC3753-3.5-26 | In distribution | |
| SC3753-3-14 | In distribution | |
| SC3802-4-23 | In distribution | |
| SC3916-3-12 | In distribution | |
| SC3916-3-13 | In distribution | |
| SC3803-2.5-20 | In distribution | |
| SC3802-1-16 | In distribution | |
| SC3802-4-17 | In distribution | |
| SC3802-4-30 | In distribution | |
| SC3916-5-10 | In distribution | |
| SC3754-2-16 | In distribution | |
| SC3753-2.5-10 | In distribution | |
| SC3916-3.5-23 | In distribution | |
| SC3754-3.5-12 | In distribution | |
| SC3916-4-11 | In distribution | |
| SC3802-5-11 | In distribution | |
| SC3803-5-13 | In distribution | |
| SC3916-2.5-16 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
| TriVerse Meniscal Insert AS | Signature Orthopaedics PTY Limited | 126 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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.