BKS E-Vitalize
Size 1 12mm Tibial Insert PS, Vitamin E
8manufacturers in China registered for this device type
193catalogue 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 | Ortho Development Corp., 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, Exporter |
| 510(k) | K152169 |
| Record published | 2015-12-21 |
| Record revised | 2024-02-28 (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 |
| Sizes | Height 7 to 41 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 166-7508 | Height 8 mm | In distribution |
| 166-7513 | Height 13 mm | In distribution |
| 166-6414 | Height 14 mm | In distribution |
| 166-6614 | Height 14 mm | In distribution |
| 166-5112 | Height 12 mm | In distribution |
| 166-7514 | Height 14 mm | In distribution |
| 166-5209 | Height 9 mm | In distribution |
| 166-5410 | Height 10 mm | In distribution |
| 166-6708 | Height 8 mm | In distribution |
| 166-6518 | Height 18 mm | In distribution |
| 166-7613 | Height 13 mm | In distribution |
| 166-6411 | Height 11 mm | In distribution |
| 166-7609 | Height 9 mm | In distribution |
| 166-5609 | Height 9 mm | In distribution |
| 166-5512 | Height 12 mm | In distribution |
| 166-6212 | Height 12 mm | In distribution |
| 166-7509 | Height 9 mm | In distribution |
| 166-6111 | Height 11 mm | In distribution |
| 166-6712 | Height 12 mm | In distribution |
| 166-7216 | Height 16 mm | In distribution |
| 166-6707 | Height 7 mm | In distribution |
| 166-7308 | Height 8 mm | In distribution |
| 166-5314 | Height 14 mm | In distribution |
| 166-6213 | Height 13 mm | In distribution |
| 166-5114 | Height 14 mm | In distribution |
| 166-6413 | Height 13 mm | In distribution |
| 166-7618 | Height 18 mm | In distribution |
| 166-6620 | Height 20 mm | In distribution |
| 166-6311 | Height 11 mm | In distribution |
| 166-6312 | Height 12 mm | In distribution |
| 166-5710 | Height 10 mm | In distribution |
| 166-6408 | Height 8 mm | In distribution |
| 166-6307 | Height 7 mm | In distribution |
| 166-7716 | Height 16 mm | In distribution |
| 166-6512 | Height 12 mm | In distribution |
| 166-7516 | Height 16 mm | In distribution |
| 166-7708 | Height 8 mm | In distribution |
| 166-6709 | Height 9 mm | In distribution |
| 166-5518 | Height 18 mm | In distribution |
| 166-6114 | Height 14 mm | In distribution |
| 166-7413 | Height 13 mm | In distribution |
| 166-5514 | Height 14 mm | In distribution |
| 166-5208 | Height 8 mm | In distribution |
| 166-7720 | Height 20 mm | In distribution |
| 166-7210 | Height 10 mm | In distribution |
| 166-7410 | Height 10 mm | In distribution |
| 166-7416 | Height 16 mm | In distribution |
| 166-6611 | Height 11 mm | In distribution |
| 166-6410 | Height 10 mm | In distribution |
| 166-7110 | Height 10 mm | In distribution |
| 166-6208 | Height 8 mm | In distribution |
| 166-7309 | Height 9 mm | In distribution |
| 166-6112 | Height 12 mm | In distribution |
| 166-7213 | Height 13 mm | In distribution |
| 166-5311 | Height 11 mm | In distribution |
| 166-7511 | Height 11 mm | In distribution |
| 166-7220 | Height 20 mm | In distribution |
| 166-5413 | Height 13 mm | In distribution |
| 166-7318 | Height 18 mm | In distribution |
| 166-7420 | Height 20 mm | In distribution |
| 166-5412 | Height 12 mm | In distribution |
| 166-7714 | Height 14 mm | In distribution |
| 166-5612 | Height 12 mm | In distribution |
| 166-6608 | Height 8 mm | In distribution |
| 166-5508 | Height 8 mm | In distribution |
| 166-7707 | Height 7 mm | In distribution |
| 166-5511 | Height 11 mm | In distribution |
| 166-6710 | Height 10 mm | In distribution |
| 166-5213 | Height 13 mm | In distribution |
| 166-6607 | Height 7 mm | In distribution |
| 166-7218 | Height 18 mm | In distribution |
| 166-5718 | Height 18 mm | In distribution |
| 166-6714 | Height 14 mm | In distribution |
| 166-7311 | Height 11 mm | In distribution |
| 166-6220 | Height 20 mm | In distribution |
| 166-7409 | Height 9 mm | In distribution |
| 166-6313 | Height 13 mm | In distribution |
| 166-5109 | Height 9 mm | In distribution |
| 166-6120 | Height 20 mm | In distribution |
| 166-7211 | Height 11 mm | In distribution |
| 166-7510 | Height 10 mm | In distribution |
| 166-7114 | Height 14 mm | In distribution |
| 166-7709 | Height 9 mm | In distribution |
| 166-6514 | Height 14 mm | In distribution |
| 166-7512 | Height 12 mm | In distribution |
| 164-5032 | Height 32 mm | In distribution |
| 166-6310 | Height 10 mm | In distribution |
| 166-7411 | Height 11 mm | In distribution |
| 166-6113 | Height 13 mm | In distribution |
| 166-6418 | Height 18 mm | In distribution |
| 166-7320 | Height 20 mm | In distribution |
| 166-6716 | Height 16 mm | In distribution |
| 166-6713 | Height 13 mm | In distribution |
| 166-7408 | Height 8 mm | In distribution |
| 164-5038 | Height 38 mm | In distribution |
| 166-7616 | Height 16 mm | In distribution |
| 166-6118 | Height 18 mm | In distribution |
| 166-7713 | Height 13 mm | In distribution |
| 166-6612 | Height 12 mm | In distribution |
| 166-7412 | Height 12 mm | In distribution |
| 166-6416 | Height 16 mm | In distribution |
| 166-6510 | Height 10 mm | In distribution |
| 166-7214 | Height 14 mm | In distribution |
| 166-7712 | Height 12 mm | In distribution |
| 166-6609 | Height 9 mm | In distribution |
| 166-6407 | Height 7 mm | In distribution |
| 166-5107 | Height 7 mm | In distribution |
| 166-6110 | Height 10 mm | In distribution |
| 166-6618 | Height 18 mm | In distribution |
| 166-6409 | Height 9 mm | In distribution |
| 166-6214 | Height 14 mm | In distribution |
| 166-7107 | Height 7 mm | In distribution |
| 166-7407 | Height 7 mm | In distribution |
| 166-5307 | Height 7 mm | In distribution |
| 166-7312 | Height 12 mm | In distribution |
| 166-6613 | Height 13 mm | In distribution |
| 166-6516 | Height 16 mm | In distribution |
| 166-6109 | Height 9 mm | In distribution |
| 166-5318 | Height 18 mm | In distribution |
| 166-7316 | Height 16 mm | In distribution |
| 166-6508 | Height 8 mm | In distribution |
| 166-6610 | Height 10 mm | In distribution |
| 166-5712 | Height 12 mm | In distribution |
| 166-6513 | Height 13 mm | In distribution |
| 166-6420 | Height 20 mm | In distribution |
| 166-6210 | Height 10 mm | In distribution |
| 166-6711 | Height 11 mm | In distribution |
| 166-6720 | Height 20 mm | In distribution |
| 166-7112 | Height 12 mm | In distribution |
| 166-7109 | Height 9 mm | In distribution |
| 166-7520 | Height 20 mm | In distribution |
| 166-6108 | Height 8 mm | In distribution |
| 166-5611 | Height 11 mm | In distribution |
| 166-5607 | Height 7 mm | In distribution |
| 166-7113 | Height 13 mm | In distribution |
| 166-7518 | Height 18 mm | In distribution |
| 166-5211 | Height 11 mm | In distribution |
| 166-6507 | Height 7 mm | In distribution |
| 166-6616 | Height 16 mm | In distribution |
| 166-5513 | Height 13 mm | In distribution |
| 166-6309 | Height 9 mm | In distribution |
| 166-6316 | Height 16 mm | In distribution |
| 166-7418 | Height 18 mm | In distribution |
| 166-7118 | Height 18 mm | In distribution |
| 166-7414 | Height 14 mm | In distribution |
| 166-5218 | Height 18 mm | In distribution |
| 166-7710 | Height 10 mm | In distribution |
| 166-7310 | Height 10 mm | In distribution |
| 166-7108 | Height 8 mm | In distribution |
| 166-7116 | Height 16 mm | In distribution |
| 166-7607 | Height 7 mm | In distribution |
| 166-7209 | Height 9 mm | In distribution |
| 166-7208 | Height 8 mm | In distribution |
| 166-6211 | Height 11 mm | In distribution |
| 166-6216 | Height 16 mm | In distribution |
| 166-7307 | Height 7 mm | In distribution |
| 166-6412 | Height 12 mm | In distribution |
| 166-7608 | Height 8 mm | In distribution |
| 166-6511 | Height 11 mm | In distribution |
| 166-7612 | Height 12 mm | In distribution |
| 166-7711 | Height 11 mm | In distribution |
| 166-7207 | Height 7 mm | In distribution |
| 166-7314 | Height 14 mm | In distribution |
| 166-6718 | Height 18 mm | In distribution |
| 166-7610 | Height 10 mm | In distribution |
| 166-7611 | Height 11 mm | In distribution |
| 166-6320 | Height 20 mm | In distribution |
| 166-7507 | Height 7 mm | In distribution |
| 166-6318 | Height 18 mm | In distribution |
| 166-7120 | Height 20 mm | In distribution |
| 166-5414 | Height 14 mm | In distribution |
| 166-6218 | Height 18 mm | In distribution |
| 166-5420 | Height 20 mm | In distribution |
| 166-6116 | Height 16 mm | In distribution |
| 166-7614 | Height 14 mm | In distribution |
| 166-6520 | Height 20 mm | In distribution |
| 164-5041 | Height 41 mm | In distribution |
| 166-7111 | Height 11 mm | In distribution |
| 166-7313 | Height 13 mm | In distribution |
| 166-6209 | Height 9 mm | In distribution |
| 166-5708 | Height 8 mm | In distribution |
| 166-6314 | Height 14 mm | In distribution |
| 166-5520 | Height 20 mm | In distribution |
| 166-6207 | Height 7 mm | In distribution |
| 166-5110 | Height 10 mm | In distribution |
| 166-7718 | Height 18 mm | In distribution |
| 166-7212 | Height 12 mm | In distribution |
| 166-6509 | Height 9 mm | In distribution |
| 166-7620 | Height 20 mm | In distribution |
| 166-5309 | Height 9 mm | In distribution |
| 166-6308 | Height 8 mm | In distribution |
| 166-5407 | Height 7 mm | In distribution |
| 166-6107 | Height 7 mm | 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 |
| 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.