Optimotion Blue CR Hccr Total Knee System
Tibial Insert Trial CR Univ-Sz 8, 13mm
8manufacturers in China registered for this device type
84catalogue 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 | Optimotion Implants, LLC, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191084 |
| Record published | 2020-07-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1014-4-8013 | In distribution | |
| 1014-3-0010 | In distribution | |
| 1014-4-0061 | In distribution | |
| 1014-3-3610 | In distribution | |
| 1014-4-7011 | In distribution | |
| 1014-4-8009 | In distribution | |
| 1014-4-1013 | In distribution | |
| 1014-5-0004 | In distribution | |
| 1014-5-0005 | In distribution | |
| 1014-4-4013 | In distribution | |
| 1014-4-6011 | In distribution | |
| 1014-F-4102 | In distribution | |
| 1014-3-3109 | In distribution | |
| 1014-2-4008 | In distribution | |
| 1014-5-0009 | In distribution | |
| 1014-5-1850 | In distribution | |
| 1014-5-0007 | In distribution | |
| 1014-3-0012 | In distribution | |
| 1014-3-2708 | In distribution | |
| 1014-3-0017 | In distribution | |
| 1014-4-7009 | In distribution | |
| 1014-5-1250 | In distribution | |
| 1014-5-2015 | In distribution | |
| 1014-4-0068 | In distribution | |
| 1014-3-0015 | In distribution | |
| 1014-4-6013 | In distribution | |
| 1014-4-5013 | In distribution | |
| 1014-4-7013 | In distribution | |
| 1014-4-2009 | In distribution | |
| 1014-4-4011 | In distribution | |
| 1014-5-1050 | In distribution | |
| 1014-5-2250 | In distribution | |
| 1014-3-3309 | In distribution | |
| 1014-5-0008 | In distribution | |
| 1014-5-1415 | In distribution | |
| 1014-3-0014 | In distribution | |
| 1014-4-0065 | In distribution | |
| 1014-4-6009 | In distribution | |
| 1014-4-5011 | In distribution | |
| 1014-3-0013 | In distribution | |
| 1014-2-4004 | In distribution | |
| 1014-5-1615 | In distribution | |
| 1014-3-0011 | In distribution | |
| 1014-4-0064 | In distribution | |
| 1014-4-3009 | In distribution | |
| 1014-2-0059 | In distribution | |
| 1014-5-1215 | In distribution | |
| 1014-5-1001 | In distribution | |
| 1014-2-4005 | In distribution | |
| 1014-5-2215 | In distribution | |
| 1014-5-2005 | In distribution | |
| 1014-5-1005 | In distribution | |
| 1014-5-1605 | In distribution | |
| 1014-5-0006 | In distribution | |
| 1014-4-1011 | In distribution | |
| 1014-5-1815 | In distribution | |
| 1014-5-1015 | In distribution | |
| 1014-4-0066 | In distribution | |
| 1014-4-1009 | In distribution | |
| 1014-4-4009 | In distribution | |
| 1014-2-4006 | In distribution | |
| 1014-4-2011 | In distribution | |
| 1014-4-0062 | In distribution | |
| 1014-4-2013 | In distribution | |
| 1014-3-3911 | In distribution | |
| 1014-4-0063 | In distribution | |
| 1014-5-2050 | In distribution | |
| 1014-5-0003 | In distribution | |
| 1014-5-1805 | In distribution | |
| 1014-5-1002 | In distribution | |
| 1014-4-0067 | In distribution | |
| 1014-2-4007 | In distribution | |
| 1014-3-0016 | In distribution | |
| 1014-5-2205 | In distribution | |
| 1014-5-1405 | In distribution | |
| 1014-3-2908 | In distribution | |
| 1014-4-5009 | In distribution | |
| 1014-5-1450 | In distribution | |
| 1014-4-3013 | In distribution | |
| 1014-3-0009 | In distribution | |
| 1014-5-1650 | In distribution | |
| 1014-4-8011 | In distribution | |
| 1014-4-3011 | In distribution | |
| 1014-5-1205 | 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.