Apex Knee System
Primary Tibial Baseplate Cemented, Pegged, size 4 Right
12manufacturers in China registered for this device type
124catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Omni Life Science, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Record published | 2021-09-23 |
| Record revised | 2021-09-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KC-2804R | In distribution | |
| KC-2805R | In distribution | |
| EP-22310 | In distribution | |
| EP-22610 | In distribution | |
| EP-20520 | In distribution | |
| EP-22316 | In distribution | |
| EC-35011 | In distribution | |
| EP-22212 | In distribution | |
| EP-20112 | In distribution | |
| EP-20111 | In distribution | |
| EP-20511 | In distribution | |
| KP-10090 | In distribution | |
| EC-36033 | In distribution | |
| KP-22113 | In distribution | |
| EP-20514 | In distribution | |
| EC-40268 | In distribution | |
| EP-22416 | In distribution | |
| EP-20320 | In distribution | |
| KP-20313 | In distribution | |
| KC-2801L | In distribution | |
| EP-20616 | In distribution | |
| EP-20311 | In distribution | |
| EP-24516 | In distribution | |
| EC-40410 | In distribution | |
| EP-22220 | In distribution | |
| KP-0255R | In distribution | |
| EP-20318 | In distribution | |
| EC-35023 | In distribution | |
| EC-36066 | In distribution | |
| EP-24120 | In distribution | |
| EP-22620 | In distribution | |
| KP-31101 | In distribution | |
| EP-22114 | In distribution | |
| EC-36058 | In distribution | |
| EC-36020 | In distribution | |
| EP-20210 | In distribution | |
| EP-22410 | In distribution | |
| EP-20120 | In distribution | |
| EP-20410 | In distribution | |
| EP-20510 | In distribution | |
| EC-35056 | In distribution | |
| EP-24216 | In distribution | |
| EP-24328 | In distribution | |
| EP-20216 | In distribution | |
| EP-24512 | In distribution | |
| EP-22413 | In distribution | |
| KC-50029 | In distribution | |
| EP-20512 | In distribution | |
| EC-36018 | In distribution | |
| EC-36016 | In distribution | |
| KP-45101 | In distribution | |
| EC-35040 | In distribution | |
| EC-35030 | In distribution | |
| EP-24524 | In distribution | |
| KC-52004 | In distribution | |
| EC-35043 | In distribution | |
| EP-20218 | In distribution | |
| EC-36049 | In distribution | |
| EP-22618 | In distribution | |
| KC-2802R | In distribution | |
| KC-2802L | In distribution | |
| EP-24416 | In distribution | |
| EC-36028 | In distribution | |
| EC-36053 | In distribution | |
| EP-22214 | In distribution | |
| EP-22420 | In distribution | |
| KC-2803R | In distribution | |
| EC-40358 | In distribution | |
| EP-24520 | In distribution | |
| EP-24410 | In distribution | |
| EC-35060 | In distribution | |
| EP-22211 | In distribution | |
| EP-24428 | In distribution | |
| EC-36039 | In distribution | |
| EP-24212 | In distribution | |
| EP-22520 | In distribution | |
| EP-24111 | In distribution | |
| KC-50027 | In distribution | |
| EC-36059 | In distribution | |
| KC-2803L | In distribution | |
| EC-35036 | In distribution | |
| EC-36036 | In distribution | |
| EP-22511 | In distribution | |
| EP-20316 | In distribution | |
| EC-36014 | In distribution | |
| KP-0065L | In distribution | |
| EC-35053 | In distribution | |
| EP-22213 | In distribution | |
| EC-35020 | In distribution | |
| EC-36064 | In distribution | |
| KC-50026 | In distribution | |
| KC-53304 | In distribution | |
| EC-36062 | In distribution | |
| EP-24124 | In distribution | |
| KC-50028 | In distribution | |
| EC-36048 | In distribution | |
| EP-24510 | In distribution | |
| EP-22612 | In distribution | |
| EC-35016 | In distribution | |
| KC-1465R | In distribution | |
| EP-24318 | In distribution | |
| EP-22116 | In distribution | |
| KP-43101 | In distribution | |
| EC-40298 | In distribution | |
| EP-24214 | In distribution | |
| KC-53300 | In distribution | |
| EP-20610 | In distribution | |
| EP-20516 | In distribution | |
| KP-20613 | In distribution | |
| EP-22513 | In distribution | |
| EP-22613 | In distribution | |
| EP-22616 | In distribution | |
| KP-0265L | In distribution | |
| EP-22110 | In distribution | |
| EC-35050 | In distribution | |
| KP-41101 | In distribution | |
| KP-0255L | In distribution | |
| EP-22311 | In distribution | |
| EP-20420 | In distribution | |
| EP-20613 | In distribution | |
| EC-36026 | In distribution | |
| EP-22216 | In distribution | |
| KP-22513 | In distribution | |
| KP-44101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080842 | 2008-05-23 |
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.