Truliant, Activit-E
CR NEUTRAL tibial insert
8manufacturers in China registered for this device type
272catalogue 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 | Exactech, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K223252 |
| Record published | 2023-09-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-024-65-3015 | In distribution | |
| 02-024-51-0013 | In distribution | |
| 02-024-47-2517 | In distribution | |
| 02-024-47-4514 | In distribution | |
| 02-024-65-9119 | In distribution | |
| 02-024-35-5011 | In distribution | |
| 02-024-51-0011 | In distribution | |
| 02-024-65-9225 | In distribution | |
| 02-024-44-4013 | In distribution | |
| 02-024-35-3510 | In distribution | |
| 02-024-51-2015 | In distribution | |
| 02-024-65-9217 | In distribution | |
| 02-023-03-0032 | In distribution | |
| 02-024-35-1013 | In distribution | |
| 02-024-51-5013 | In distribution | |
| 02-024-44-1014 | In distribution | |
| 02-024-65-9311 | In distribution | |
| 02-024-44-2509 | In distribution | |
| 02-024-65-3021 | In distribution | |
| 02-024-51-2514 | In distribution | |
| 02-024-35-1517 | In distribution | |
| 02-024-35-6013 | In distribution | |
| 02-024-51-1015 | In distribution | |
| 02-024-44-3510 | In distribution | |
| 02-024-35-6014 | In distribution | |
| 02-024-65-5017 | In distribution | |
| 02-024-35-6015 | In distribution | |
| 02-024-44-4010 | In distribution | |
| 02-024-65-9421 | In distribution | |
| 02-024-51-3510 | In distribution | |
| 02-024-51-4009 | In distribution | |
| 02-024-35-1009 | In distribution | |
| 02-024-51-5014 | In distribution | |
| 02-023-07-0032 | In distribution | |
| 02-024-65-9411 | In distribution | |
| 02-024-35-1017 | In distribution | |
| 02-023-07-0035 | In distribution | |
| 02-024-65-2025 | In distribution | |
| 02-024-47-6014 | In distribution | |
| 02-024-65-1029 | In distribution | |
| 02-024-44-5009 | In distribution | |
| 02-024-44-5015 | In distribution | |
| 02-024-35-1514 | In distribution | |
| 02-024-51-4510 | In distribution | |
| 02-024-44-3015 | In distribution | |
| 02-024-44-2517 | In distribution | |
| 02-024-51-3519 | In distribution | |
| 02-024-65-9425 | In distribution | |
| 02-024-47-5010 | In distribution | |
| 02-024-47-3013 | In distribution | |
| 02-024-35-2012 | In distribution | |
| 02-024-35-6010 | In distribution | |
| 02-024-35-3519 | In distribution | |
| 02-024-65-2029 | In distribution | |
| 02-024-65-9321 | In distribution | |
| 02-024-51-4514 | In distribution | |
| 02-024-51-6012 | In distribution | |
| 02-024-35-2519 | In distribution | |
| 02-024-47-4010 | In distribution | |
| 02-024-51-1515 | In distribution | |
| 02-024-47-3009 | In distribution | |
| 02-024-65-2017 | In distribution | |
| 02-024-65-3029 | In distribution | |
| 02-024-35-5019 | In distribution | |
| 02-024-44-3515 | In distribution | |
| 02-024-47-5013 | In distribution | |
| 02-024-65-4013 | In distribution | |
| 02-023-03-0026 | In distribution | |
| 02-024-35-4515 | In distribution | |
| 02-024-44-6012 | In distribution | |
| 02-024-47-1013 | In distribution | |
| 02-023-02-0041 | In distribution | |
| 02-024-47-5015 | In distribution | |
| 02-024-35-1515 | In distribution | |
| 02-024-44-3514 | In distribution | |
| 02-023-03-0029 | In distribution | |
| 02-024-47-6015 | In distribution | |
| 02-024-51-0019 | In distribution | |
| 02-024-51-4010 | In distribution | |
| 02-024-65-1017 | In distribution | |
| 02-024-35-1509 | In distribution | |
| 02-024-35-4011 | In distribution | |
| 02-024-35-4010 | In distribution | |
| 02-024-35-2510 | In distribution | |
| 02-024-51-1011 | In distribution | |
| 02-024-47-6013 | In distribution | |
| 02-024-47-3515 | In distribution | |
| 02-024-65-9129 | In distribution | |
| 02-024-47-3014 | In distribution | |
| 02-024-47-1009 | In distribution | |
| 02-024-35-4015 | In distribution | |
| 02-024-51-3015 | In distribution | |
| 02-024-44-5019 | In distribution | |
| 02-024-51-5015 | In distribution | |
| 02-024-47-5009 | In distribution | |
| 02-024-44-6014 | In distribution | |
| 02-024-65-5025 | In distribution | |
| 02-024-51-6011 | In distribution | |
| 02-024-44-1015 | In distribution | |
| 02-024-51-1009 | In distribution | |
| 02-024-44-1011 | In distribution | |
| 02-024-47-6017 | In distribution | |
| 02-024-65-3013 | In distribution | |
| 02-024-47-6012 | In distribution | |
| 02-024-47-4013 | In distribution | |
| 02-024-65-5009 | In distribution | |
| 02-024-65-9315 | In distribution | |
| 02-024-44-6019 | In distribution | |
| 02-024-44-3014 | In distribution | |
| 02-024-51-5009 | In distribution | |
| 02-024-51-2517 | In distribution | |
| 02-024-65-9125 | In distribution | |
| 02-024-51-4015 | In distribution | |
| 02-024-51-1010 | In distribution | |
| 02-024-44-1511 | In distribution | |
| 02-024-44-1510 | In distribution | |
| 02-024-47-4017 | In distribution | |
| 02-024-65-2015 | In distribution | |
| 02-024-44-0009 | In distribution | |
| 02-024-35-3513 | In distribution | |
| 02-024-44-3012 | In distribution | |
| 02-024-51-4019 | In distribution | |
| 02-024-51-1014 | In distribution | |
| 02-024-35-2509 | In distribution | |
| 02-024-47-6009 | In distribution | |
| 02-024-35-1513 | In distribution | |
| 02-024-44-6015 | In distribution | |
| 02-024-35-4517 | In distribution | |
| 02-024-51-6019 | In distribution | |
| 02-024-35-1014 | In distribution | |
| 02-024-44-4511 | In distribution | |
| 02-024-47-1512 | In distribution | |
| 02-024-47-2512 | In distribution | |
| 02-024-35-4512 | In distribution | |
| 02-024-47-4510 | In distribution | |
| 02-024-65-9419 | In distribution | |
| 02-024-51-6009 | In distribution | |
| 02-024-47-0012 | In distribution | |
| 02-024-65-4011 | In distribution | |
| 02-024-44-2515 | In distribution | |
| 02-024-47-2509 | In distribution | |
| 02-024-35-6017 | In distribution | |
| 02-024-65-4019 | In distribution | |
| 02-024-44-1512 | In distribution | |
| 02-024-65-4017 | In distribution | |
| 02-024-35-3515 | In distribution | |
| 02-024-35-4009 | In distribution | |
| 02-024-65-1011 | In distribution | |
| 02-024-51-6017 | In distribution | |
| 02-024-35-3017 | In distribution | |
| 02-024-44-1513 | In distribution | |
| 02-024-65-4009 | In distribution | |
| 02-024-44-1019 | In distribution | |
| 02-024-47-2017 | In distribution | |
| 02-024-51-3511 | In distribution | |
| 02-024-47-2012 | In distribution | |
| 02-024-65-2013 | In distribution | |
| 02-024-65-5019 | In distribution | |
| 02-024-47-2514 | In distribution | |
| 02-024-47-4513 | In distribution | |
| 02-024-35-2513 | In distribution | |
| 02-024-44-2012 | In distribution | |
| 02-024-65-9417 | In distribution | |
| 02-024-51-3014 | In distribution | |
| 02-024-44-2010 | In distribution | |
| 02-024-51-1512 | In distribution | |
| 02-024-35-0013 | In distribution | |
| 02-024-44-5011 | In distribution | |
| 02-024-51-3517 | In distribution | |
| 02-024-47-4015 | In distribution | |
| 02-024-35-4519 | In distribution | |
| 02-024-51-0010 | In distribution | |
| 02-024-44-4512 | In distribution | |
| 02-024-51-2014 | In distribution | |
| 02-024-47-1513 | In distribution | |
| 02-024-35-2019 | In distribution | |
| 02-024-44-5012 | In distribution | |
| 02-024-51-1013 | In distribution | |
| 02-024-51-3019 | In distribution | |
| 02-024-51-2009 | In distribution | |
| 02-024-51-4509 | In distribution | |
| 02-024-47-6010 | In distribution | |
| 02-024-65-5013 | In distribution | |
| 02-024-35-1510 | In distribution | |
| 02-024-51-2511 | In distribution | |
| 02-024-44-0010 | In distribution | |
| 02-024-65-9109 | In distribution | |
| 02-024-44-2019 | In distribution | |
| 02-024-47-2010 | In distribution | |
| 02-024-35-0015 | In distribution | |
| 02-024-47-2511 | In distribution | |
| 02-024-65-2019 | In distribution | |
| 02-024-47-1017 | In distribution | |
| 02-024-65-3017 | In distribution | |
| 02-024-35-6019 | In distribution | |
| 02-024-65-9319 | In distribution | |
| 02-024-65-4025 | In distribution | |
| 02-024-44-4515 | In distribution | |
| 02-024-47-0017 | In distribution | |
| 02-024-44-5017 | In distribution | |
| 02-024-44-1519 | In distribution | |
| 02-024-47-2013 | In distribution | |
| 02-024-47-0013 | In distribution | |
| 02-024-65-4029 | In distribution | |
| 02-024-65-9115 | In distribution | |
| 02-024-44-1515 | In distribution | |
| 02-024-65-1009 | In distribution | |
| 02-024-35-1512 | In distribution | |
| 02-024-44-2514 | In distribution | |
| 02-024-35-3013 | In distribution | |
| 02-024-44-4513 | In distribution | |
| 02-024-65-3009 | In distribution | |
| 02-024-65-9429 | In distribution | |
| 02-024-35-0014 | In distribution | |
| 02-024-47-3015 | In distribution | |
| 02-024-51-2513 | In distribution | |
| 02-024-65-9211 | In distribution | |
| 02-024-51-4011 | In distribution | |
| 02-024-44-3011 | In distribution | |
| 02-024-44-4012 | In distribution | |
| 02-024-51-5011 | In distribution | |
| 02-024-35-6009 | In distribution | |
| 02-023-07-0026 | In distribution | |
| 02-024-35-0011 | In distribution | |
| 02-024-47-4517 | In distribution | |
| 02-024-47-4509 | In distribution | |
| 02-024-35-3514 | In distribution | |
| 02-024-44-2015 | In distribution | |
| 02-024-51-2512 | In distribution | |
| 02-024-35-4013 | In distribution | |
| 02-024-44-0017 | In distribution | |
| 02-024-51-4511 | In distribution | |
| 02-024-47-3510 | In distribution | |
| 02-024-51-1511 | In distribution | |
| 02-024-51-5010 | In distribution | |
| 02-024-35-1011 | In distribution | |
| 02-024-51-6013 | In distribution | |
| 02-024-47-3012 | In distribution | |
| 02-024-65-5021 | In distribution | |
| 02-024-51-3012 | In distribution | |
| 02-024-44-3519 | In distribution | |
| 02-024-47-3513 | In distribution | |
| 02-024-51-2515 | In distribution | |
| 02-024-35-4019 | In distribution | |
| 02-024-44-2013 | In distribution | |
| 02-024-44-3511 | In distribution | |
| 02-024-44-1009 | In distribution | |
| 02-024-51-2019 | In distribution | |
| 02-024-44-4014 | In distribution | |
| 02-024-44-4019 | In distribution |
Showing 250 of 272 catalogue numbers.
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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
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.