Sigma
Sigma High Performance Partial Knee Tibial Insert Fixed Bearing Unicondylar Size 1 RM/LL 10MM
8manufacturers in China registered for this device type
28catalogue numbers in this listing
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 | Depuy (Ireland), Ireland |
|---|---|
| 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K193549 |
| Record published | 2021-04-23 |
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 |
|---|---|---|
| 1024-56-110 | In distribution | |
| 1024-55-211 | In distribution | |
| 1024-55-107 | In distribution | |
| 1024-56-307 | In distribution | |
| 1024-55-209 | In distribution | |
| 1024-56-510 | In distribution | |
| 1024-56-611 | In distribution | |
| 1024-55-610 | In distribution | |
| 1024-56-610 | In distribution | |
| 1024-55-408 | In distribution | |
| 1024-56-508 | In distribution | |
| 1024-56-310 | In distribution | |
| 1024-55-410 | In distribution | |
| 1024-56-210 | In distribution | |
| 1024-55-508 | In distribution | |
| 1024-56-609 | In distribution | |
| 1024-55-509 | In distribution | |
| 1024-55-611 | In distribution | |
| 1024-56-410 | In distribution | |
| 1024-56-408 | In distribution | |
| 1024-56-411 | In distribution | |
| 1024-56-107 | In distribution | |
| 1024-56-111 | In distribution | |
| 1024-55-607 | In distribution | |
| 1024-56-109 | In distribution | |
| 1024-55-207 | In distribution | |
| 1024-55-608 | In distribution | |
| 1024-55-510 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| 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 |
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.