Finn Knee System
138 catalogue numbers from 153820, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
138catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| 510(k) | K945028 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 153820 | 22 MM 89 MM | In distribution |
| 153841 | In distribution | |
| 154044 | 11 MM 152 MM | In distribution |
| 154076 | 71 MM 47.3 MM | In distribution |
| CP163821 | 12.5 MM 152 MM | In distribution |
| 154090 | 67 MM 11 MM 152MM STEM | In distribution |
| 180029 | 31 CM | In distribution |
| 153818 | 18 MM 89 MM | In distribution |
| 153934 | In distribution | |
| 154091 | 67 MM 13 MM 152MM STEM | In distribution |
| 154009 | 63 MM 42.2 MM | In distribution |
| 153806 | 5 CM | In distribution |
| 154059 | 15 MM 152 MM | In distribution |
| 153911 | 10MM THICK 83 MM | In distribution |
| 154082 | 67 MM | In distribution |
| 154048 | 11 MM 152 MM | In distribution |
| 153816 | 14 MM 89 MM | In distribution |
| 153828 | 17 MM 152 MM | In distribution |
| 154089 | 67 MM 13 MM 152MM STEM | In distribution |
| 153903 | 10MM THICK 67/71 MM | In distribution |
| 154077 | 75 MM 48.1 MM | In distribution |
| 154085 | 11 MM 152 MM 2 CM COLLAR | In distribution |
| 153814 | 11 MM 89 MM | In distribution |
| 154011 | 67 MM 44.6 MM | In distribution |
| 153851 | In distribution | |
| 154068 | 17 MM 152 MM | In distribution |
| 154063 | 15 MM 152 MM | In distribution |
| 153813 | 10 MM 89 MM | In distribution |
| 180037 | 47 cm | In distribution |
| 154084 | 9 MM 152 MM 2 CM COLLAR | In distribution |
| 154066 | 17 MM 152 MM | In distribution |
| CP163827 | 18.5 MM 152 MM | In distribution |
| CP163815 | 13.5 MM 89 MM | In distribution |
| 180031 | 35 cm | In distribution |
| 154051 | 13 MM 152 MM | In distribution |
| 180033 | 39 CM | In distribution |
| 153917 | 20MM THICK 75/79 MM | In distribution |
| 180025 | 7 CM TYPE I TAPER | In distribution |
| 153829 | 18 MM 152 MM | In distribution |
| 153805 | 5 CM | In distribution |
| 180028 | 29 cm | In distribution |
| CP163817 | 17.5 MM 89 MM | In distribution |
| 154052 | 13 MM 152 MM | In distribution |
| 154083 | 67 MM | In distribution |
| 153907 | 10MM THICK 75/79 MM | In distribution |
| CP163820 | 23.5 MM 89 MM | In distribution |
| CP163825 | 16.5 MM 152 MM | In distribution |
| 154086 | 13 MM 152 MM 2 CM COLLAR | In distribution |
| 154062 | 15 MM 152 MM | In distribution |
| 153916 | 20MM THICK 75/79 MM | In distribution |
| 154072 | 17 MM 152 MM | In distribution |
| 154081 | 67 MM | In distribution |
| 154040 | 17 MM 152 MM | In distribution |
| 154080 | 67 MM | In distribution |
| 153906 | 10MM THICK 75/79 MM | In distribution |
| CP163828 | 19.5 MM 152 MM | In distribution |
| 153910 | 10MM THICK 83 MM | In distribution |
| 153803 | 8 CM | In distribution |
| 153866 | In distribution | |
| 153933 | LARGE SIZE | In distribution |
| 180035 | 43 CM | In distribution |
| 154071 | 17 MM 152 MM | In distribution |
| 154046 | 11 MM 152 MM | In distribution |
| 153913 | 20MM THICK 67/71 MM | In distribution |
| 153809 | 15.5 MM 152 MM | In distribution |
| 153826 | 16 MM 152 MM | In distribution |
| 154049 | 13 MM 152 MM | In distribution |
| 154065 | 17 MM 152 MM | In distribution |
| 154070 | 17 MM 152 MM | In distribution |
| 153912 | 20MM THICK 67/71 MM | In distribution |
| CP163824 | 15.5 MM 152 MM | In distribution |
| 153902 | 10MM THICK 67/71 MM | In distribution |
| 154079 | 83 MM 55.3 MM | In distribution |
| CP163818 | 19.5 MM 89 MM | In distribution |
| 153924 | 3.5 MM | In distribution |
| 154058 | 15 MM 152 MM | In distribution |
| 153921 | 20MM THICK 83 MM | In distribution |
| 154078 | 79 MM 52.6 MM | In distribution |
| CP163819 | 21.5 MM 89 MM | In distribution |
| 154056 | 13 MM 152 MM | In distribution |
| 180039 | 51 CM | In distribution |
| 153992 | 22 MM | In distribution |
| 180026 | 7 CM TYPE I TAPER | In distribution |
| 153804 | 8 CM | In distribution |
| 154042 | 11 MM 152 MM | In distribution |
| 154064 | 15 MM 152 MM | In distribution |
| CP163816 | 15.5 MM 89 MM | In distribution |
| 154067 | 17 MM 152 MM | In distribution |
| 154035 | 11 MM 152 MM | In distribution |
| 180024 | 7 CM TYPE I TAPER | In distribution |
| 153852 | In distribution | |
| 180038 | 49 CM | In distribution |
| 154039 | 15 MM 152 MM | In distribution |
| CP163823 | 14.5 MM 152 MM | In distribution |
| 153986 | 16 MM | In distribution |
| 154047 | 11 MM 152 MM | In distribution |
| 153815 | 12 MM 89 MM | In distribution |
| 153920 | 20MM THICK 83 MM | In distribution |
| 154050 | 13 MM 152 MM | In distribution |
| 180032 | 37 cm | In distribution |
| 180030 | 33 CM | In distribution |
| 154075 | 67 MM 44.6 MM | In distribution |
| 154054 | 13 MM 152 MM | In distribution |
| 153801 | 3 CM | In distribution |
| 154060 | 15 MM 152 MM | In distribution |
| 154069 | 17 MM 152 MM | In distribution |
| 153807 | 11.5 MM 152 MM | In distribution |
| 154043 | 11 MM 152 MM | In distribution |
| 154053 | 13 MM 152 MM | In distribution |
| 153824 | 14 MM 152 MM | In distribution |
| 153984 | 14 MM | In distribution |
| 153872 | In distribution | |
| CP163826 | 17.5 MM 152 MM | In distribution |
| 153988 | 18 MM | In distribution |
| 154087 | 15 MM 152 MM 2 CM COLLAR | In distribution |
| 153802 | 3 CM | In distribution |
| CP163822 | 13.5 MM 152 MM | In distribution |
| CP163814 | 12.5 MM 89 MM | In distribution |
| 154045 | 11 MM 152 MM | In distribution |
| RD108806 | In distribution | |
| 153982 | 12 MM | In distribution |
| 154055 | 13 MM 152 MM | In distribution |
| 154041 | 11 MM 152 MM | In distribution |
| 153810 | 17.5 MM 152 MM | In distribution |
| 154093 | 67 MM 15 MM 152MM STEM | In distribution |
| 153861 | In distribution | |
| 153819 | 20 MM 89 MM | In distribution |
| 153990 | 20 MM | In distribution |
| 153822 | 12 MM 152 MM | In distribution |
| 154057 | 15 MM 152 MM | In distribution |
| 153817 | 16 MM 89 MM | In distribution |
| 180032 | 37 CM | In distribution |
| 154061 | 15 MM 152 MM | In distribution |
| 154012 | 71 MM 44.6 MM | In distribution |
| 153825 | 15 MM 152 MM | In distribution |
| 153821 | 11 MM 152 MM | In distribution |
| 153823 | 13 MM 152 MM | In distribution |
| 180028 | 29 CM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 94 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131393 | 2013-10-24 |
| K020381 | 2002-05-06 |
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.