Evolution
Evolution® 45 DG Angled Insert Impactr W/ MOD Connection Uptd
21manufacturers in China registered for this device type
596catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K233507 |
| Record published | 2019-05-31 |
| Record revised | 2023-02-03 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 10 to 24 mm; outer diameter 10 to 24 mm; length 25 to 150 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETAKN4SL | In distribution | |
| EIC3S17R | Height 17 mm | In distribution |
| ETAKN2SR | In distribution | |
| E2005212 | In distribution | |
| EIS4S14L | Height 14 mm | In distribution |
| ETH905L0 | Thickness 5 mm | In distribution |
| EIS7S17L | Height 17 mm | In distribution |
| ESRK0825 | In distribution | |
| E233CN03 | In distribution | |
| EIP6P20R | Height 20 mm | In distribution |
| EFXSNP5L | In distribution | |
| EIP8S12R | Height 12 mm | In distribution |
| ETH315MR | Thickness 15 mm | In distribution |
| ETAKN7SR | In distribution | |
| ESP16100 | Outer Diameter 16 mm | In distribution |
| EFXPNP6R | In distribution | |
| E5101CN2 | In distribution | |
| EIC6P14R | Height 14 mm | In distribution |
| EIS6P24L | Height 24 mm | In distribution |
| ETH410LL | Thickness 10 mm | In distribution |
| EIP3S12R | Height 12 mm | In distribution |
| EIC7S14R | Height 14 mm | In distribution |
| EIS6P10R | Height 10 mm | In distribution |
| EIS6P14L | Height 14 mm | In distribution |
| EIS2S17L | Height 17 mm | In distribution |
| EIP4S12R | Height 12 mm | In distribution |
| EAI2120L | Height 20 mm | In distribution |
| EAI7514R | Height 14 mm | In distribution |
| ETH315LR | Thickness 15 mm | In distribution |
| ETH810MR | Thickness 10 mm | In distribution |
| ESP16150 | Outer Diameter 16 mm | In distribution |
| EPI3120R | Height 20 mm | In distribution |
| EAI4220R | Height 20 mm | In distribution |
| EIP4S24R | Height 24 mm | In distribution |
| ETH815MR | Thickness 15 mm | In distribution |
| EIC7S10R | Height 10 mm | In distribution |
| EFPSN5SR | In distribution | |
| EIP7S24R | Height 24 mm | In distribution |
| ETH515LR | Thickness 15 mm | In distribution |
| EFSRN4PR | In distribution | |
| EIP6S20R | Height 20 mm | In distribution |
| EIC6S12R | Height 12 mm | In distribution |
| EIC4S17R | Height 17 mm | In distribution |
| ETH305M0 | Thickness 5 mm | In distribution |
| EIP6P24R | Height 24 mm | In distribution |
| EPI3114R | Height 14 mm | In distribution |
| ETAKN8SR | In distribution | |
| ETKNCN04 | In distribution | |
| ETH905M0 | Thickness 5 mm | In distribution |
| E5101CN3 | In distribution | |
| EPI2114R | Height 14 mm | In distribution |
| EIP6S14R | Height 14 mm | In distribution |
| EFSRP5PL | In distribution | |
| E2432CN02 | In distribution | |
| EIP8S14R | Height 14 mm | In distribution |
| EPI4217R | Height 17 mm | In distribution |
| EIP2P10R | Height 10 mm | In distribution |
| EIS7P14L | Height 14 mm | In distribution |
| EIP1S12R | Height 12 mm | In distribution |
| EIS4P17L | Height 17 mm | In distribution |
| E2432CN13 | In distribution | |
| EIC2S17R | Height 17 mm | In distribution |
| ETKNCN06 | In distribution | |
| EFSAN3PL | In distribution | |
| ETH605L0 | Thickness 5 mm | In distribution |
| EIP2S14R | Height 14 mm | In distribution |
| EIP2P24R | Height 24 mm | In distribution |
| EIS4S10R | Height 10 mm | In distribution |
| EIS5P17L | Height 17 mm | In distribution |
| ETH210LL | Thickness 10 mm | In distribution |
| EFSRN2PR | In distribution | |
| ETH215MR | Thickness 15 mm | In distribution |
| EIS8S14L | Height 14 mm | In distribution |
| EIS5P20L | Height 20 mm | In distribution |
| EIS3S12L | Height 12 mm | In distribution |
| EIP4S14R | Height 14 mm | In distribution |
| EAI4112L | Height 12 mm | In distribution |
| EAI4120L | Height 20 mm | In distribution |
| EAI8514R | Height 14 mm | In distribution |
| E3500CN1 | In distribution | |
| EFXSNP3L | In distribution | |
| EFXPNP5R | In distribution | |
| EFSRN7RL | In distribution | |
| EAI5312L | Height 12 mm | In distribution |
| ETH715MR | Thickness 15 mm | In distribution |
| EFSRP8PL | In distribution | |
| ETH815ML | Thickness 15 mm | In distribution |
| EFSAN2PR | In distribution | |
| ESP19100 | Length 100 mm | In distribution |
| ETH810ML | Thickness 10 mm | In distribution |
| ETH410ML | Thickness 10 mm | In distribution |
| ETH715ML | Thickness 15 mm | In distribution |
| ESP10100 | Length 100 mm | In distribution |
| EFSAN2PL | In distribution | |
| EIS3S10R | Height 10 mm | In distribution |
| ESP19150 | Length 150 mm | In distribution |
| ETH705M0 | Thickness 5 mm | In distribution |
| EIS3S17L | Height 17 mm | In distribution |
| ESC14075 | Outer Diameter 14 mm | In distribution |
| EAI6420R | Height 20 mm | In distribution |
| EIP6P14R | Height 14 mm | In distribution |
| ETH605M0 | Thickness 5 mm | In distribution |
| EFXSNP6R | In distribution | |
| EIC6S17R | Height 17 mm | In distribution |
| EAI2110L | Height 10 mm | In distribution |
| ETH915ML | Thickness 15 mm | In distribution |
| EIC2P10R | Height 10 mm | In distribution |
| EFSAN1PR | In distribution | |
| EIS5P10R | Height 10 mm | In distribution |
| EIP2S10R | Height 10 mm | In distribution |
| EFPSN4SR | In distribution | |
| ETRKN2SR | In distribution | |
| ETH615MR | Thickness 15 mm | In distribution |
| EIS7S24L | Height 24 mm | In distribution |
| ETRKN4SR | In distribution | |
| ESS00001 | In distribution | |
| ETH310LL | Thickness 10 mm | In distribution |
| EPI7414R | Height 14 mm | In distribution |
| EIP1S14R | Height 14 mm | In distribution |
| E3500CK1 | In distribution | |
| EAI6320R | Height 20 mm | In distribution |
| ETH515LL | Thickness 15 mm | In distribution |
| EIS4P12L | Height 12 mm | In distribution |
| ETH910LR | Thickness 10 mm | In distribution |
| ETH310LR | Thickness 10 mm | In distribution |
| E233CN06 | In distribution | |
| EFSAN7PL | In distribution | |
| EFSRN3PR | In distribution | |
| ESC00000 | In distribution | |
| E233CN02 | In distribution | |
| ETPKN4SR | In distribution | |
| ETAKN2PL | In distribution | |
| EFSAN4PR | In distribution | |
| EIP5S12R | Height 12 mm | In distribution |
| EIS3P10R | Height 10 mm | In distribution |
| ESP14150 | Length 150 mm | In distribution |
| EFXPNP7L | In distribution | |
| EIS2S14L | Height 14 mm | In distribution |
| ETAKN6PL | In distribution | |
| EIC5S14R | Height 14 mm | In distribution |
| EIP6P17R | Height 17 mm | In distribution |
| EFXSNP6L | In distribution | |
| E3005111 | In distribution | |
| ETH615LR | Thickness 15 mm | In distribution |
| ESP12150 | Outer Diameter 12 mm | In distribution |
| EIC6P12R | Height 12 mm | In distribution |
| EAI7510R | Height 10 mm | In distribution |
| EIS1P14L | Height 14 mm | In distribution |
| EFSAN6PL | In distribution | |
| ETRKN7SL | In distribution | |
| EPI7510R | Height 10 mm | In distribution |
| EAI3112L | Height 12 mm | In distribution |
| EIS8S17L | Height 17 mm | In distribution |
| EAI7517L | Height 17 mm | In distribution |
| EIS1P20L | Height 20 mm | In distribution |
| EAI8520R | Height 20 mm | In distribution |
| EAI6414L | Height 14 mm | In distribution |
| EAI5314L | Height 14 mm | In distribution |
| ESS00003 | In distribution | |
| EIC2P12R | Height 12 mm | In distribution |
| ETAKN3SR | In distribution | |
| ETH610ML | Thickness 10 mm | In distribution |
| EFSAN4PL | In distribution | |
| ESP13100 | Outer Diameter 13 mm | In distribution |
| ETAKN5SR | In distribution | |
| ETH810LL | Thickness 10 mm | In distribution |
| ETH610LR | Thickness 10 mm | In distribution |
| EAI4210L | Height 10 mm | In distribution |
| EFSAN5PR | In distribution | |
| E233CN05 | In distribution | |
| EIS8S20L | Height 20 mm | In distribution |
| ETH510LR | Thickness 10 mm | In distribution |
| EIP7S12R | Height 12 mm | In distribution |
| EFSRP2PL | In distribution | |
| EFPSN6SR | In distribution | |
| ESC17025 | Outer Diameter 17 mm | In distribution |
| ETH410MR | Thickness 10 mm | In distribution |
| EIP2S17R | Height 17 mm | In distribution |
| EIC2P17R | Height 17 mm | In distribution |
| EIS2S10R | Height 10 mm | In distribution |
| EIC1S12R | Height 12 mm | In distribution |
| EIC8S10R | Height 10 mm | In distribution |
| EIP6S12R | Height 12 mm | In distribution |
| EIS3S24L | Height 24 mm | In distribution |
| EIP7S14R | Height 14 mm | In distribution |
| ETH410LR | Thickness 10 mm | In distribution |
| EIP7S20R | Height 20 mm | In distribution |
| ETH610LL | Thickness 10 mm | In distribution |
| ETH805M0 | Thickness 5 mm | In distribution |
| ETH710ML | Thickness 10 mm | In distribution |
| E203CN02 | In distribution | |
| EIS4S17L | Height 17 mm | In distribution |
| ETH510MR | Thickness 10 mm | In distribution |
| EIS4S24L | Height 24 mm | In distribution |
| EIP4S10R | Height 10 mm | In distribution |
| EIP8S24R | Height 24 mm | In distribution |
| ETPKN6PR | In distribution | |
| ESP14100 | Outer Diameter 14 mm | In distribution |
| ETAKN6SR | In distribution | |
| EAI7520R | Height 20 mm | In distribution |
| EIS4P24L | Height 24 mm | In distribution |
| ESC12075 | Outer Diameter 12 mm | In distribution |
| ETH805L0 | Thickness 5 mm | In distribution |
| ETH415LL | Thickness 15 mm | In distribution |
| EAI6410R | Height 10 mm | In distribution |
| EIS7P17L | Height 17 mm | In distribution |
| EFSRN5RL | In distribution | |
| EAI4117L | Height 17 mm | In distribution |
| EAI6417L | Height 17 mm | In distribution |
| EFXSNP7R | In distribution | |
| EFSAN5PL | In distribution | |
| ETH110LR | Thickness 10 mm | In distribution |
| EIS3P12L | Height 12 mm | In distribution |
| EIS1P24L | Height 24 mm | In distribution |
| EFXPNP3L | In distribution | |
| EIS1S14L | Height 14 mm | In distribution |
| EAI7512R | Height 12 mm | In distribution |
| EIS2S24L | Height 24 mm | In distribution |
| EIC4S14R | Height 14 mm | In distribution |
| EIS6P12L | Height 12 mm | In distribution |
| E2432CN12 | In distribution | |
| ETH310ML | Thickness 10 mm | In distribution |
| EPI7517R | Height 17 mm | In distribution |
| EFSRN5RR | In distribution | |
| ETH915LL | Thickness 15 mm | In distribution |
| ESP22100 | Length 100 mm | In distribution |
| EIS7S10R | Height 10 mm | In distribution |
| ETH710LL | Thickness 10 mm | In distribution |
| EFPSN8PR | In distribution | |
| EPI6414R | Height 14 mm | In distribution |
| EFSRN4RL | In distribution | |
| EIC3S12R | Height 12 mm | In distribution |
| EIP6S24R | Height 24 mm | In distribution |
| EIP4S20R | Height 20 mm | In distribution |
| ETAKN1SL | In distribution | |
| EIS5P12L | Height 12 mm | In distribution |
| ETRKN1SR | In distribution | |
| EIS5S24L | Height 24 mm | In distribution |
| ETRKMK36 | In distribution | |
| EAI3110L | Height 10 mm | In distribution |
| ETH210MR | Thickness 10 mm | In distribution |
| ESRK0025 | In distribution | |
| EFXSNP7L | In distribution | |
| ETH405L0 | Thickness 5 mm | In distribution |
| EIC5S10R | Height 10 mm | In distribution |
| EIP5S10R | Height 10 mm | In distribution |
| ETRKMK78 | In distribution | |
| EIS3P17L | Height 17 mm | In distribution |
| ETH815LR | Thickness 15 mm | In distribution |
| EIS6S20L | Height 20 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243574 | 2025-02-18 |
| K231947 | 2023-10-31 |
| K182125 | 2018-12-06 |
| K171389 | 2017-08-08 |
| K162026 | 2017-03-01 |
| K142550 | 2014-11-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Microport Orthopedics Inc. | 510(k) number | 2024-10-29 | Class II | Labeling Change Control | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging. | 32 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-02-02 | Class II | Device Design | Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product. | 17 units | 2015-03-19 |
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.