Apex Revision Knee
PS Revision Tibial Locking Bolt Modular Tibia - 24mm
12manufacturers in China registered for this device type
92catalogue 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 | 2015-11-27 |
| Record revised | 2023-02-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
|---|---|---|
| KP-24410 | In distribution | |
| KP-24510 | In distribution | |
| KP-24412 | In distribution | |
| KC-54030 | In distribution | |
| KP-3110L | In distribution | |
| KC-52502 | In distribution | |
| KC-52522 | In distribution | |
| KC-50135 | In distribution | |
| KC-52572 | In distribution | |
| KP-24320 | In distribution | |
| KC-50137 | In distribution | |
| KP-24212 | In distribution | |
| KC-50172 | In distribution | |
| KP-44050 | In distribution | |
| KC-52352 | In distribution | |
| KP-24528 | In distribution | |
| KC-50177 | In distribution | |
| KP-0415L | In distribution | |
| KC-52354 | In distribution | |
| KC-52304 | In distribution | |
| KC-52004 | In distribution | |
| KC-52154 | In distribution | |
| KP-3110R | In distribution | |
| KP-0445R | In distribution | |
| KC-50132 | In distribution | |
| KP-44100 | In distribution | |
| KC-50230 | In distribution | |
| KC-50097 | In distribution | |
| KC-54020 | In distribution | |
| KC-52754 | In distribution | |
| KP-4310R | In distribution | |
| KC-50217 | In distribution | |
| KC-52022 | In distribution | |
| KP-31050 | In distribution | |
| KP-24411 | In distribution | |
| KP-4415L | In distribution | |
| KP-24318 | In distribution | |
| KP-24114 | In distribution | |
| KC-50252 | In distribution | |
| KP-24511 | In distribution | |
| KC-50192 | In distribution | |
| KC-50190 | In distribution | |
| KP-31100 | In distribution | |
| KP-42050 | In distribution | |
| KP-24424 | In distribution | |
| KP-24420 | In distribution | |
| KP-39024 | In distribution | |
| KP-4510L | In distribution | |
| KC-52574 | In distribution | |
| KP-24218 | In distribution | |
| KC-52054 | In distribution | |
| KC-52324 | In distribution | |
| KP-24210 | In distribution | |
| KP-0425R | In distribution | |
| KC-52024 | In distribution | |
| KP-39020 | In distribution | |
| KP-0410R | In distribution | |
| KP-39018 | In distribution | |
| KP-24328 | In distribution | |
| KC-54050 | In distribution | |
| KC-52704 | In distribution | |
| KC-50155 | In distribution | |
| KP-0455L | In distribution | |
| KC-52552 | In distribution | |
| KP-24124 | In distribution | |
| KP-24214 | In distribution | |
| KC-52122 | In distribution | |
| KC-50170 | In distribution | |
| KC-52972 | In distribution | |
| KP-4215L | In distribution | |
| KP-24518 | In distribution | |
| KP-4215R | In distribution | |
| KP-42100 | In distribution | |
| KP-24311 | In distribution | |
| KP-0455R | In distribution | |
| KC-52752 | In distribution | |
| KP-4515R | In distribution | |
| KC-50150 | In distribution | |
| KC-52974 | In distribution | |
| KP-4210R | In distribution | |
| KP-4410L | In distribution | |
| KP-39014 | In distribution | |
| KP-24110 | In distribution | |
| KP-0435L | In distribution | |
| KC-50197 | In distribution | |
| KC-52774 | In distribution | |
| KP-24211 | In distribution | |
| KP-24228 | In distribution | |
| KP-24216 | In distribution | |
| KP-43050 | In distribution | |
| KP-4315R | In distribution | |
| KP-39028 | 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.