Evolution
Evolution® Femoral Finish Impactr W/ MOD Connection Uptd
12manufacturers in China registered for this device type
57catalogue numbers in this listing
8510(k) clearances naming this product code
12recalls on this code
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 | Microport Orthopedics 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 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K894334 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETPSB6SL | In distribution | |
| ETPK1534 | In distribution | |
| ETPSB4SR | In distribution | |
| ETPLB6SL | In distribution | |
| EFSRP7PL | In distribution | |
| ETPSB8PL | In distribution | |
| ETPLB6SR | In distribution | |
| ETPSB4SL | In distribution | |
| ETPLB8SL | In distribution | |
| ETPLB1SR | In distribution | |
| ETPSB2SL | In distribution | |
| E1005111 | In distribution | |
| ETPSB8SR | In distribution | |
| EFSRP6PR | In distribution | |
| ETPLB2PL | In distribution | |
| ETPSB6PL | In distribution | |
| ETPSB6SR | In distribution | |
| ETPSB3SL | In distribution | |
| ETPSB2PR | In distribution | |
| ETPSB1SL | In distribution | |
| ETPSB2PL | In distribution | |
| ETPSB7SL | In distribution | |
| ETPK1578 | In distribution | |
| ETPK1512 | In distribution | |
| ETPSB7SR | In distribution | |
| ETPSB2SR | In distribution | |
| ETPLB4SR | In distribution | |
| ETPSB5SR | In distribution | |
| ETPLB4SL | In distribution | |
| ETPLB3SL | In distribution | |
| ETPLB3SR | In distribution | |
| ETPLB6PR | In distribution | |
| ETPLB7SL | In distribution | |
| ETPLB2SR | In distribution | |
| EFSRP3PR | In distribution | |
| EFSRP1PL | In distribution | |
| ETPSB3SR | In distribution | |
| ETPLB6PL | In distribution | |
| ETPSB8PR | In distribution | |
| ETPSB1SR | In distribution | |
| ETPLB2SL | In distribution | |
| EFSRP1PR | In distribution | |
| ETPLB8SR | In distribution | |
| ETPLB7SR | In distribution | |
| ETPLB1SL | In distribution | |
| ETPSB8SL | In distribution | |
| ETPLB5SR | In distribution | |
| ETPLB8PL | In distribution | |
| ETPLB5SL | In distribution | |
| EFSRP3PL | In distribution | |
| ETPSB6PR | In distribution | |
| ETPLB2PR | In distribution | |
| ETPSB5SL | In distribution | |
| E1005212 | In distribution | |
| ETPK1556 | In distribution | |
| ETPLB8PR | In distribution | |
| EFSRP5PR | 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 |
|---|---|
| K253728 | 2026-08-21 |
| K233507 | 2024-01-18 |
| K213817 | 2022-01-05 |
| K180317 | 2018-05-04 |
| K170288 | 2017-06-15 |
| K152298 | 2015-11-16 |
| K143366 | 2015-01-21 |
| K140735 | 2014-08-29 |
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
11 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 98 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 47 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 86 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 110 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 34 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 38 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 134 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 77 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 36 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 169 units | 2017-07-26 |
| 2016-06-21 | Class I | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | 60 units | 2017-07-26 |
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.