Evolution
The EVOLUTION Hinge Knee System is a constrained, hinged total knee system for cemented use in skeletally mature patients. The filing describes its role in knee arthroplasty for specified…
The EVOLUTION Hinge Knee System is a constrained, hinged total knee system for cemented use in skeletally mature patients. The filing describes its role in knee arthroplasty for specified joint diseases, functional deformity, revision procedures after other treatments fail, and certain fractures.
The system is a line extension to the EVOLUTION Revision knee portfolio. Its components include a femoral component in seven sizes and a hinge yoke assembly with size options based on femur size. The FDA summary also describes compatibility with selected previously cleared stems, keels and patellae.
Listed Item
Evolution Hinge CUT Thru Stem 5 DEG Adapter, Size 5, Right
System Components and Use
The filing specifies cemented use only and lists selected components compatible with prior clearances. It also identifies components that are not for use with the Hinge tibial bases.
7manufacturers in China registered for this device type
223catalogue 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 | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230563 |
| Record published | 2025-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E1200313 | In distribution | |
| E520555L | In distribution | |
| E120552L | In distribution | |
| E3500114 | In distribution | |
| E2432230 | In distribution | |
| E2432190 | In distribution | |
| E1720121 | In distribution | |
| E2513152 | In distribution | |
| E3500512 | In distribution | |
| E2546051 | In distribution | |
| E520566R | In distribution | |
| E120554R | In distribution | |
| E2230125 | In distribution | |
| E3500312 | In distribution | |
| E120564L | In distribution | |
| E520555R | In distribution | |
| E63043HR | In distribution | |
| E3500524 | In distribution | |
| E2332004 | In distribution | |
| E2432200 | In distribution | |
| E520564R | In distribution | |
| E120558L | In distribution | |
| E120556R | In distribution | |
| E3500120 | In distribution | |
| E1205778 | In distribution | |
| E1204542 | In distribution | |
| E120562L | In distribution | |
| E1205805 | In distribution | |
| E3500412 | In distribution | |
| E1205746 | In distribution | |
| E120567L | In distribution | |
| E1716682 | In distribution | |
| E1205723 | In distribution | |
| E2432015 | In distribution | |
| E1204543 | In distribution | |
| E520556R | In distribution | |
| E120565R | In distribution | |
| E3500214 | In distribution | |
| E2513101 | In distribution | |
| E1716122 | In distribution | |
| E1204557 | In distribution | |
| E520567L | In distribution | |
| E1204546 | In distribution | |
| E1204544 | In distribution | |
| E520556L | In distribution | |
| E3500420 | In distribution | |
| E2031004 | In distribution | |
| E120566R | In distribution | |
| E3500620 | In distribution | |
| E2331001 | In distribution | |
| E520557R | In distribution | |
| E120567R | In distribution | |
| E3500112 | In distribution | |
| E3500714 | In distribution | |
| E3500720 | In distribution | |
| E63046HL | In distribution | |
| E2331008 | In distribution | |
| E520567R | In distribution | |
| E3500612 | In distribution | |
| E2331005 | In distribution | |
| E2332009 | In distribution | |
| E120556L | In distribution | |
| E120564R | In distribution | |
| E3500614 | In distribution | |
| E1204548 | In distribution | |
| E1205508 | In distribution | |
| E3500712 | In distribution | |
| E120557R | In distribution | |
| E3500814 | In distribution | |
| E2031002 | In distribution | |
| E3500314 | In distribution | |
| E63047HR | In distribution | |
| E520566L | In distribution | |
| E3500117 | In distribution | |
| E63043HL | In distribution | |
| E2432002 | In distribution | |
| E6002001 | In distribution | |
| E120568L | In distribution | |
| E120558R | In distribution | |
| E1204552 | In distribution | |
| E3500414 | In distribution | |
| E2578052 | In distribution | |
| E2432240 | In distribution | |
| E1720351 | In distribution | |
| E2546052 | In distribution | |
| E63044HR | In distribution | |
| E520558L | In distribution | |
| E2513151 | In distribution | |
| E3500320 | In distribution | |
| E2331006 | In distribution | |
| E3500517 | In distribution | |
| E120562R | In distribution | |
| E2332002 | In distribution | |
| E1205502 | In distribution | |
| E1204558 | In distribution | |
| E2513052 | In distribution | |
| E6002003 | In distribution | |
| E3500417 | In distribution | |
| E63042HL | In distribution | |
| E2331004 | In distribution | |
| E120568R | In distribution | |
| E3500824 | In distribution | |
| E3500124 | In distribution | |
| E1205506 | In distribution | |
| E1720122 | In distribution | |
| E3500520 | In distribution | |
| E2432150 | In distribution | |
| E2332003 | In distribution | |
| E1716351 | In distribution | |
| E120553R | In distribution | |
| E2578152 | In distribution | |
| E3500817 | In distribution | |
| E2432140 | In distribution | |
| E120552R | In distribution | |
| E1716681 | In distribution | |
| E1716352 | In distribution | |
| E2230225 | In distribution | |
| E2332008 | In distribution | |
| E120563R | In distribution | |
| E63045HR | In distribution | |
| E520565R | In distribution | |
| E2546101 | In distribution | |
| E2332007 | In distribution | |
| E2333001 | In distribution | |
| E1720682 | In distribution | |
| E120566L | In distribution | |
| E2578101 | In distribution | |
| E1200118 | In distribution | |
| E2331007 | In distribution | |
| E520554R | In distribution | |
| E3500224 | In distribution | |
| E1205810 | In distribution | |
| E2332006 | In distribution | |
| E2432210 | In distribution | |
| E120555R | In distribution | |
| E2331009 | In distribution | |
| E2432160 | In distribution | |
| E520563R | In distribution | |
| E1200045 | In distribution | |
| E520568L | In distribution | |
| E3500217 | In distribution | |
| E520552L | In distribution | |
| E2332001 | In distribution | |
| E2432180 | In distribution | |
| E1205800 | In distribution | |
| E3500212 | In distribution | |
| E1200067 | In distribution | |
| E3500317 | In distribution | |
| E6002002 | In distribution | |
| E1205503 | In distribution | |
| E1720681 | In distribution | |
| E120563L | In distribution | |
| E63046HR | In distribution | |
| E2578102 | In distribution | |
| E6300003 | In distribution | |
| E1204547 | In distribution | |
| E2578151 | In distribution | |
| E2578051 | In distribution | |
| E3500324 | In distribution | |
| E2432100 | In distribution | |
| E120553L | In distribution | |
| E2546152 | In distribution | |
| E2031003 | In distribution | |
| E2432170 | In distribution | |
| E120557L | In distribution | |
| E2513051 | In distribution | |
| E2031001 | In distribution | |
| E63048HL | In distribution | |
| E1205504 | In distribution | |
| E520552R | In distribution | |
| E3500220 | In distribution | |
| E1204512 | In distribution | |
| E2546102 | In distribution | |
| E2331003 | In distribution | |
| E520565L | In distribution | |
| E120554L | In distribution | |
| E63042HR | In distribution | |
| E2432120 | In distribution | |
| E520562L | In distribution | |
| E520553R | In distribution | |
| E2331010 | In distribution | |
| E3500717 | In distribution | |
| E520562R | In distribution | |
| E120565L | In distribution | |
| E520563L | In distribution | |
| E2432010 | In distribution | |
| E3500624 | In distribution | |
| E520558R | In distribution | |
| E120555L | In distribution | |
| E3500617 | In distribution | |
| E1200008 | In distribution | |
| E2432130 | In distribution | |
| E630128R | In distribution | |
| E1205507 | In distribution | |
| E63048HR | In distribution | |
| E3500812 | In distribution | |
| E2432220 | In distribution | |
| E520564L | In distribution | |
| E2332005 | In distribution | |
| E1205505 | In distribution | |
| E520553L | In distribution | |
| E520554L | In distribution | |
| E630128L | In distribution | |
| E63044HL | In distribution | |
| E3500724 | In distribution | |
| E3500514 | In distribution | |
| E3500424 | In distribution | |
| E2432110 | In distribution | |
| E520557L | In distribution | |
| E1720352 | In distribution | |
| E2333002 | In distribution | |
| E2331002 | In distribution | |
| E1716121 | In distribution | |
| E2432001 | In distribution | |
| E2432005 | In distribution | |
| E63045HL | In distribution | |
| E3500820 | In distribution | |
| E2513102 | In distribution | |
| E2546151 | In distribution | |
| E63047HL | In distribution | |
| E520568R | In distribution | |
| E1200023 | In distribution | |
| E1204545 | 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 |
| 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 |
| Finn Knee System | Biomet Orthopedics | 138 |
| 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 |
|---|---|
| K240043 | 2024-04-01 |
| K230563 | 2023-09-27 |
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.